Posted by jrbecker on October 8, 2003, at 11:23:13
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Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Panelists: Larry Culpepper, MD, MPH; K. Ranga R. Krishnan, MB, ChB; Kurt Kroenke, MD; Jerrold F. Rosenbaum, MD; Jeffrey L. Susman, MD; Michael E. Thase, MD; Moderator: Peter L. Salgo, MD; CME Activity Director: Matthew Menza, MD
The print monograph was reviewed for relevance, accuracy of content, balance of presentation, and time required for participation by Matthew Menza, MD; Sheetal Chhaya, DO; Shanthi Lewis, MD; and Cindy Yeung, DO. The video presentation was reviewed by Matthew Menza, MD; Camille Horton, MD; and Victoria Raiwe, MD.
Copyright © 2003 UMDNJ–Center for Continuing and Outreach Education and Liberty Communications Network.
This CME activity is based on a Medical Crossfire presentation as delivered by the faculty, which was held at the Museum of Science in Boston on May 14, 2003.Faculty affiliations and disclosures are at the end of this activity.
--------------------------------------------------------------------------------Release Date: September 24, 2003; Valid for credit through September 24, 2004
Target Audience
This educational activity is designed for psychiatrists, primary-care physicians, and other health care professionals interested in or involved with the management of depression and anxiety disorders.Goal
Although many experts agree that remission should be the outcome of treatment for depression and anxiety disorders, response is more often the goal that is used to measure efficacy of management in both clinical trials and the practice setting. Applying evidence-based medicine has been emphasized as one means of improving the treatment of these disorders. However, obstacles to the implementation of evidence-based medicine remain, and, despite its potential benefits on the provision of care, evidence-based medicine has not been widely translated into psychiatric practice. In addition, clinicians are still faced with general challenges that prevent the achievement of remission in their patient populations. Why is the path to remission so critical? What are the key elements for a successful management strategy, and how can evidence-based medicine be applied? How do currently available medications differ in their abilities to achieve remission in patients with depression and anxiety disorders, and what evidence-based data are currently available to support these therapeutic choices?Through debate and authoritative peer exchange, this activity, based on the proceedings of a live Medical Crossfire program conducted in conjunction with the University of Medicine & Dentistry of New Jersey, will confront current clinical challenges and evidence-based perspectives associated with achieving remission in depression and anxiety disorders.
Learning Objectives
Upon completion of this activity, participants will be able to:
Discuss the rationale and criteria for remission and functional recovery as primary management goals for depression and anxiety disorders.
Delineate the clinical barriers to achieving remission and the potential consequences of failure.
Discuss the practical application of evidence-based medicine in the management of depression and anxiety disorders.
Compare current therapeutic options and their effectiveness in achieving remission from an evidence-based perspective.
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Contents of This CME Activity
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Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Introduction
The Remission Challenge
Remission: A Better Goal?
Evidence-Based Medicine and Psychiatric Care
Achieving Remission Through Evidence-Based Medicine
Final Thoughts
References
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Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety DisordersIntroduction
Although epidemiological and clinical evidence supports the feasibility — and desirability — of remission as the therapeutic goal in depression and anxiety disorders,[1-4] a disturbing gap exists between research and practice.[5-7] In both the primary-care and psychiatric settings, many clinicians have been satisfied with achieving response rather than remission.[3] This situation has been attributed, first, to response being the common primary endpoint in clinical therapeutic trials and, second, to clinicians being reluctant to adopt the principles of evidence-based medicine.[1,8-11] Because improved patient outcomes can be obtained through evidence-based medicine, it is critical that practitioners become confident in applying its principles in the treatment of all diseases — including mental health disorders. Contributing to that goal, this Medical Crossfire among a panel of national experts in psychiatry and primary care was convened, stated moderator Peter L. Salgo, MD, "to examine the clinical challenges and evidence-based perspectives associated with achieving remission in depression and anxiety disorders."
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
The Remission Challenge
Defining Remission
Clinical trials have shown that a higher proportion of patients with depression and anxiety achieve response than remission, despite the numerous advantages of full recovery.[3] "How is remission defined in depression and generalized anxiety disorder, and how does remission differ from response?" began Dr. Salgo."We measure these illnesses in terms of the clinical burden of the signs and symptoms and how that affects patients in their day-to-day lives," responded Michael E. Thase, MD. "Remission, in the simplest terms, is complete relief of the signs and symptoms of the disorder and a return to the patient's usual level of functioning. The level of improvement should make the patient indistinguishable from a person who has never been ill."
"For many people, depression is lifelong," pointed out Jerrold F. Rosenbaum, MD, who added a qualification to Dr. Thase's definition of remission. "These patients may continue to have residual or minor symptoms, and for them, the usual level of function may actually be short of remission."
"That is correct," agreed Dr. Thase. "If a patient has been chronically ill, getting better, at first, will not mean a restoration of full functioning. There will be two levels of improvement to achieve remission." He added that "there are research tools that can be modified for clinical practice to quantify symptoms and assess the patient's current function."
"Is it possible for primary-care physicians to use these assessment tools?" inquired Dr. Salgo. "Or are they best handled by a psychiatrist?"
"One of the limitations of depression care for primary-care practitioners is that some of the tools used by psychiatrists are relatively lengthy and complicated," replied Kurt Kroenke, MD, citing as examples the Hamilton Rating Scale for Depression (HAM-D) and the Hamilton Rating Scale for Anxiety (HAM-A).
"Using these tools is not as easy as obtaining a blood pressure reading in the patient with hypertension or a blood glucose measurement in the patient with diabetes. We have some simpler clinical tools, like the Patient Health Questionnaire (PHQ-9), that support staff can use to measure a patient's depression before he is even seen by the physician. Then the physician can begin the visit with an understanding of the patient's depression and use her time more wisely."
"I completely agree that most of the available instruments are not adequate in terms of primary care," seconded Larry Culpepper, MD. With this dearth of primary-care clinical tools, Dr. Culpepper has devised his own strategy for assessing patients' short-term and long-term well-being. "In the short term, I identify the cardinal symptoms that brought the patient to me and track progress on these symptoms every week or two during the acute phase of treatment. For long-term assessment, I find it helpful to ask patients, 'What activity did you enjoy, but gave up when you became depressed?' I had a patient who had once enjoyed gardening and making a weekly trip to the library. I knew she was improving the spring she put in a garden; I knew remission was maintained when she renewed her weekly library trips that winter."
Affirming Dr. Culpepper's approach, Dr. Thase observed, "Certainly, it is well within the scope of primary care to know your patients, to understand what troubles them and interferes with their functioning, and to talk with them about how their day-to-day lives are going."
Response: A Valid Goal?
"What about the opinion that a complete remission for every patient is out of the question, and that we should be happy to achieve 50% improvement in anxiety disorders and depressive disorders?" queried Dr. Salgo."We have used the term response for many years; it is a term that clinicians are accustomed to hearing. But response is not an outcome, it is a measure of change," replied Dr. Rosenbaum. He explained that response — usually defined as 50% reduction from baseline total scores on the HAM-D — is used in clinical trials "to determine whether a therapy is having more of an effect than placebo.[12,13] Response should be considered only a point on the path to remission — the point on the path where the patient is better but not well. It is reasonable, in the setting of a clinical trial, to rely on response as a measure of a drug's efficacy. But in a practice setting, 50% improvement is no bargain for the patient. The patient may present with a HAM-D of 30, and the clinician may get it down to a 15, but the patient has one life to live, and he should not have to live it at a 15."
"That is why having quick, simple, primary-care-oriented assessment tools would be so helpful," interjected Jeffrey L. Susman, MD. He cited Dr. Kroenke's work on the PHQ-9, a patient-administered, shortened version of the PRIME-MD diagnostic instrument for mental disorders. The PHQ-9, which focuses on depression, was validated by Dr. Kroenke and his colleagues[14] as a rapid and reliable assessment tool for clinical and research use. With this tool, explained Dr. Susman, "I can track a patient over time and determine not only whether there has been an initial response but also whether he has achieved or is close to achieving remission. Clinical tools are very helpful in ensuring the diligence to not accept a partial response or not lose focus half way to remission."
"How easy is it to do these assessments in primary care, when practitioners often have limited time to see a patient under managed care?" challenged Dr. Salgo.
Dr. Susman suggested two strategies: first, involve the whole health care team; and, second, do not use these tools to screen general populations. "If I have my nurse using a PHQ-9 with a selected patient before I even walk into the examination room, then, yes, I can treat the patient with depression very comfortably in a short visit."
"The physician doesn't measure blood pressure levels; the nurse does it. Depression can be measured in a similar way, with the physician looking at the results," agreed Dr. Kroenke.
"Let me add a different perspective," interjected K. Ranga R. Krishnan, MB, ChB. "The patient is not a HAM-D; the patient is not a laboratory result. Very often, the patient with depression has a complex and challenging interplay of depression, anxiety, and personality traits. Achieving remission is not as simple as scoring 0 on the HAM-D."
"An electrocardiogram provides information on a patient, but the clinician still has to identify the cause of the chest pain and determine the appropriate treatment," countered Dr. Kroenke. "If the clinician has information from an assessment tool as a starting point, she can actually spend more time during the patient encounter in constructive conversation."
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Remission: A Better Goal?
Dr. Salgo asked the panelists to address the importance of complete remission as a therapeutic goal. "If I am an internist, and I can get a patient's hyperglycemia or hypertension into a reasonable range, I am happy with that. Why isn't this approach good enough in depression?"
"Certainly, 15 years ago, if I could get a patient's blood glucose down to the high 180s, 200, 220, I was really happy. But now I have better measurement techniques and better therapies, and therefore I want much tighter control," replied Dr. Culpepper. "The case is the same with depression and anxiety disorders. If we get the depression under greater control, not only do patients have improved function and fewer symptoms, they have much less chance of relapse."
"Dr. Culpepper says that if the patient achieves a complete remission, he has less chance of relapse," reiterated Dr. Salgo. "Dr. Thase, is that statistically accurate?"
"Yes, it is statistically accurate," confirmed Dr. Thase. Patients who achieve complete remission with therapeutic intervention are less likely to experience relapse than are patients who do not achieve complete remission of depression.[7,15,16] In addition, patients who achieve complete remission also have more normal psychosocial and vocational functioning.[7,17] "Physiologically, human beings are dynamic, integrated systems," explained Dr. Thase. "One's mood state modifies or amplifies how one experiences life. If a person experiences a setback and already has a low mood or pessimism, the impact will be much greater than if that person were in complete remission. Carrying depressive symptoms around creates burden not only for the patient's mental and physical health but also for the patient's loved ones, employers, and other associates."
"We are starting to identify the biochemical and physiologic correlates of this 'kindling phenomenon,' whereby a person with a history of depression is more likely to have depression again," elaborated Dr. Susman. "Leaving a patient with partly treated depression means leaving that person more susceptible to recurrences, deeper depressions, and additional problems. It is absolutely critical on the frontlines of primary care to take our patients with depression as completely to remission as possible."
"It is a little unfair to tell our primary-care colleagues, given the tools they have available, that they have failed if the patient does not achieve remission," cautioned Dr. Rosenbaum. "Remission is the ideal, but the message for caregivers should be to get the patient as well as can be, given the tools available today."
"By using the word response, we might have been selling ourselves short," offered Dr. Kroenke, "but by using the word remission prematurely, we might be overselling ourselves."
"The majority of primary-care patients who do achieve remission are not there because the physician didn't push hard enough," suggested Dr. Culpepper.
Obstacles on the Road to Remission
"Dr. Susman, what are the key elements of a successful remission strategy?" queried Dr. Salgo. "And what are the common obstacles to success?"The first step, responded Dr. Susman, is reaching the right diagnosis, "which can be very challenging in primary care. The patient may have heart failure or diabetes in addition to the mood disorder. The mood disorder itself may be associated with alcohol abuse, substance abuse, anxiety, depression, or other factors." After the diagnosis is made and therapy selected, the follow-up strategy becomes critical, continued Dr. Susman. "The clinician must do all she can to confirm that the patient is responding to treatment and continuing toward remission. That may include weekly follow-up by telephone to determine that the patient is taking the medication and keeping scheduled appointments."
"The first phase of a staged approach is to improve symptoms over time," added Dr. Krishnan. "But there is also a second phase, which is often not properly addressed, and that is returning to function." He explained that "some people are depressed from the time they can remember. And if the clinician's goal is to help the patient get better, what is 'better' for that individual? Is it the best he has ever been, or is it the best he could be?" Dr. Krishnan stated his belief that the patient should not just get better but should be "returned to preexisting function or an idealized function that has never been achieved by that particular individual. Unfortunately, there is no therapeutic short cut; this requires talking and spending time with the patient, which is difficult to do in the current environment."
Dr. Rosenbaum, however, suggested that such an idealistic goal may hardly be practical in the real world of primary care, where practitioners must triage care for patients with multiple illnesses. "The physician may decide, 'Well, now that the patient's depression symptoms are better, it is time to address the conditions that aren't better.' "
Dr. Thase agreed that "depressed people have more difficult lives. They are trying to get better in the context of being underemployed, having marital difficulties or poorly behaved children, and often, as Dr. Rosenbaum noted, suffering multiple illnesses."
"One particular complication that often arises in the medical context is attributing depression to another medical illness," pointed out Dr. Krishnan. "The clinician may say, 'The patient has just had a heart attack. That is why he is depressed; there is nothing to be done.'" But evidence indicates a complex interrelationship between depression and cardiovascular disease.[18-21] Major depressive disorder occurs in 15% to 23% of patients with acute coronary syndromes and constitutes an independent risk factor for both morbidity and mortality.[20] In addition, said Dr. Krishnan, "If a patient experiences depression right after myocardial infarction — even very mild symptoms that do not constitute a full-blown episode — the odds of dying within the next six months are increased.[22]" Diabetes, stroke, HIV infection, and other chronic conditions can also interact with depression, he noted.
Dr. Krishnan then introduced the obstacle of treatment adherence. The clinician must do better, he contended, than "handing the patient a prescription and saying, 'I'll see you back in six months.' Often the prescription is never filled, or filled one time, or the pills are not used for the entire treatment course. Clearly, we are not getting the message across to the patient that adherence to treatment is critical for remission."
"I think that where we fall down on the job as clinicians is not handling the assessment at three or four weeks of therapy in a more valid way," asserted Dr. Culpepper, who suggested that "the PHQ-9 is probably our gold standard in terms of primary-care measurement of improvement. If a patient is not at least 30% better at three to four weeks, that patient needs additional attention. In primary care, most patients who are responding but are not doing well on therapy are still on the initial dose of the first drug prescribed."
Dr. Kroenke agreed that appropriate follow-up care is often neglected. "The Health Plan Employer Data and Information Set, or HEDIS, measures require three visits within 12 weeks, but only a minority of practices meet that target."
"We have been talking as if medication were the totality of treatment," offered Dr. Culpepper. "But there is a significant role for psychotherapy, and it is critical that the clinician is able to recognize the patient who needs psychotherapeutic intervention."
"Among outpatients with depression, eight to 12 weeks of psychotherapy performs as well as antidepressant medication," noted Dr. Thase. "Of course, there are still problems of access, stigma, and reimbursement, but these therapies are practical and they are very compatible with medication."
Dr. Kroenke agreed that a few evidence-based psychotherapies — cognitive-behavioral, interpersonal, and problem-solving therapies — are beneficial "in the substantial group of patients who do not achieve remission with pharmacological therapy alone." As Dr. Thase noted, access and reimbursement are problematic. "In a rural state, the clinician can write a prescription but she cannot always find a trained cognitive-behavioral therapist. And when psychotherapy is available, not all health care insurance systems will pay for it."
"Are our expectations different based on the practitioner involved?" asked Dr. Salgo. "Do our expectations for the psychiatric profession differ from those for primary care?"
"The typical primary-care physician is comfortable prescribing a wide number of antidepressant medications, but as combination or augmentation therapy, in which multiple medications are used, becomes necessary, a smaller number will be comfortable," answered Dr. Kroenke. "And, of course, primary-care physicians cannot provide psychotherapy, which requires referral to a mental health professional. Clearly, there is teamwork involved in achieving remission."
"What about nurse practitioners and physician assistants? Where do they stand?" inquired Dr. Salgo.
"Studies have found that nurse practitioners can be trained in depression care, can serve as care managers in practices, can help monitor patients, and sometimes even prescribe medicines or administer problem-solving therapy,[19]" responded Dr. Kroenke. "However, it is not always clear that this care will be reimbursed adequately."
Citing a 2002 report, "Reducing Suicide: A National Imperative," from the Institute of Medicine,23 Dr. Culpepper emphasized the importance of distinguishing depression from hopelessness, although the two may overlap. "Ninety percent of persons who commit suicide were depressed, but it is also true that the depressed patient can receive treatment, achieve remission, and still commit suicide," he stated. "And this small portion of patients are the ones who remained hopeless and did not change their outlook on life." The report offered the encouraging news that "some psychotherapies, particularly cognitive-behavioral therapy, can help these patients reflect on their lives and change their outlook from one of hopelessness," added Dr. Culpepper.
"Therefore, if I recognize that a patient at 12, 16, or 24 weeks after initiation of drug therapy remains hopeless despite having a good medication response," continued Dr. Culpepper, "then that is the patient whom I, as the primary-care physician, need to refer to a trained mental-health professional who can provide these effective psychotherapies."
"Most patients who attempt or commit suicide have recently seen a physician or a health care giver, and the suicidality has been missed because this is not a symptom we talk about," agreed Dr. Krishnan. "We ask about sadness, we ask about loss of interest, but we don't mention hopelessness, which is a core feature in both depression and suicide. I strongly agree with Dr. Culpepper that we need to educate physicians to understand this concept and recognize patients at risk."
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Evidence-Based Medicine and Psychiatric Care
Relevance in Mental Health Care
Evidence-based medicine has been defined as "the evaluation of a body of literature to make decisions about best practice."[24] "Applying evidence-based medicine has been emphasized as one means of improving the treatment of depression and anxiety, yet implementation in the practice setting has been met with real challenges," observed Dr. Salgo. "To start, what application does evidence-based medicine have for mental health care, specifically with regard to depression and anxiety disorders?""Evidence-based medicine is a concept that is only slowly being embraced in the mental health field," replied Dr. Krishnan, who traced some of this reluctance to the belief that evidence-based medicine is "cookbook medicine," requiring a rigid, formulaic approach to patient care.[6,8-11] "That impression is the farthest from the truth," he asserted. "Evidence-based medicine allows the practitioner to combine her expertise with the best available evidence and integrate them with a given patient's unique characteristics, values, and expectations.[25]"
"In the patient with heart failure, for example, I can measure the patient's weight, I can measure his ejection fraction," proposed Dr. Salgo. "But for depression and anxiety, what constitutes best evidence in psychiatry?"
"Mental illness is manifested by symptoms and decreased functioning, and the only way to get the information is by asking the patient or someone who knows the patient," replied Dr. Kroenke. "So you really do have to rely on what the patient tells you, but there are systematic ways of interviewing the patient."
Dr. Krishnan asserted that "the levels of evidence available for depression and anxiety are comparable to the levels of evidence available in many other common areas of medicine. What has not happened is translating the information and making clinicians aware of what we do know."
Benefits and Challenges
Although primary care embraces evidence-based medicine, commented Dr. Susman, "the challenge is to make it practical in practice. In the course of a day, I may see 30 or 40 patients with multiple diseases, so I have to apply the best evidence for depression at the same time that I am applying the best evidence for diabetes, congestive heart failure, asthma, and so on, in the context of each patient and his individual realities. Frankly, translating even very well done evidence-based guidelines to the individual level is often extremely challenging — even when I can find that evidence.""Of the questions that come up in primary-care practice, 40% to 50% have evidence-based answers but 50% to 60% don't and may not have even been the subject of a trial," commented Dr. Kroenke.
"Clearly, the challenge that remains in both primary care and psychiatry is translating the evidence and applying it to specific patients," agreed Dr. Culpepper. An important aspect of evidenced-based medicine in primary care is the selection of outcomes that matter to patients. "With diabetes, I can get a laboratory number that the patient does not perceive as important and drill that number down," explained Dr. Culpepper. "But in psychiatry, we look for outcomes that matter to the patient — function, outlook, symptoms. For many other chronic diseases there are not many outcome data that look beyond laboratory measures to the patient's total well-being."
"There are some critical barriers to applying evidence-based medicine in mental health care," Dr. Krishnan pointed out. "Evidence shows that certain types of psychotherapy work. But that type of psychotherapy may not be available in that area, therefore the clinician cannot do what she knows she should do. And evidence may show that a drug works, but it may be difficult to get the patient to come back at repeat intervals, to properly measure response due to time constraints, due to reimbursement, and so on."
"And wonderful studies have shown that psychiatrists and primary-care clinicians can work together to achieve better outcomes — but these results were obtained in controlled trials,[26-28]" observed Dr. Susman.
"To achieve these results in real-world practice may be impossible because of funding issues, managed care issues, carve-out issues, and other practical matters."
Practicing Evidence-Based Medicine
Faced with these barriers, proposed Dr. Susman, clinicians must "adapt evidence-based medicine to our own practice environment so it works. For example, evidence shows that remission should be our goal in the patient with depression. Our job, therefore, is to do whatever we can, given the environment we work in, to get the best response possible and not settle for an inadequate response."Dr. Kroenke offered a suggestion for adapting evidence-based medicine to clinical practice. "Evidence shows that careful follow-up improves outcome,[19] but we often depend on the patient to come back to the clinic. There are creative ways, however, to improve follow-up, including telephone contact and self-monitoring."
"There are translatable bits of knowledge from evidence-based medicine that can be applied in practice," agreed Dr. Rosenbaum. "For example, long-term outcomes will vary tremendously based on how well the patient is treated acutely; therefore, therapy must be targeted to a higher level and we must set the outcomes bar higher.[7,15,16] That is clearly translatable." However, he declared, "I take issue with some of the high regard for evidence-based psychiatry, because there are huge gaps in the evidence. Much of it is opportunistic and based on short-term trials. As for large, long-term clinical trials, it takes so long to do these trials that by the time we have the evidence, the field has probably moved on to other things." Dr. Rosenbaum offered two suggestions for the clinicians seeking to integrate evidence-based medicine into their practices: "One, we have to apply the evidence that is compelling while recognizing that there are big gaps and that each patient is different. And, two, we have to continue to apply our best judgment and use the art of medicine."
"In our struggle for autonomy, we should not proclaim that unproven medicine is better than evidence-based medicine or rely on intuition when there are scientifically proven answers," cautioned Dr. Thase. "The precision of evidence makes a difference in people's lives."
"The art of medicine is to apply the available information to your patient in a systematic manner. Evidence-based medicine is no different, except that a vast amount of knowledge has been distilled for the clinician," declared Dr. Krishnan.
"Clearly, there is a lot of debate here," observed Dr. Salgo. "Can anyone provide a roadmap for integrating evidence-based medicine into the average physician practice?"
Using screening as an example, Dr. Susman suggested, "Focus on populations that we know exhibit important comorbidities with depression: cardiovascular disease, HIV, diabetes, multiple chronic diseases. This strategy has a high yield because not only are these patients more likely to be depressed, but treatment of comorbid depression improves outcome of both the depression and the comorbid disease."
"If we cannot afford to screen everyone, there are certain subpopulations that we ought to screen," agreed Dr. Krishnan. "Screening for depression in the patient with a comorbid medical problem may affect the outcome of the very medical problem we are trying to treat."
"With evidence-based medicine, we are trying to obtain performance improvement," noted Dr. Susman. "We can achieve better outcomes by using evidence along the continuum from screening everyone to screening only a few people."
"And how can evidence-based medicine be applied to assessing progress of treatment?" queried Dr. Salgo.
"There are good evidence-based strategies to support the ongoing direct assessment of the patient's symptoms," replied Dr. Susman. Among the methods he noted are key symptoms, the PHQ-9, and other screening tools, particularly the web-available screening toolkit provided by the MacArthur Foundation at www.depression-primarycare.org.
Dr. Krishnan suggested that the use of validated assessment tools should be tailored to the individual patient. "Severity of depression and type of symptoms can be used to determine which patients should be targeted for early follow-up," he explained, providing an example. If a patient is identified as having suicidal ideation, "that patient should not be told, 'Come back in four weeks.' "
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Achieving Remission Through Evidence-Based Medicine
Research suggests that evidence-based medicine is significantly underused in the management of mental health disorders, including depression and anxiety.[29,30] "Let's bring together our discussion points so far and focus on how clinicians can adopt an evidence-based approach to achieving remission in patients with depression and anxiety disorders," suggested Dr. Salgo. "Let's start with the evidence base regarding remission and nonpharmacological therapy."
Nonpharmacological Therapy
"There are multiple studies showing the efficacy of cognitive-behavioral treatment, interpersonal psychotherapy, and problem-solving therapy,[31-34]" noted Dr. Thase. "The one most relevant to primary care is problem-solving therapy, which has been specifically developed to be performed in half-hour sessions by nurses. Several trials have been done showing that these therapies have measurable beneficial effects over eight to 12 weeks. They work as well as a single trial of antidepressant medication and confer similar remission rates. The limitations of the psychotherapies are availability and applicability to more severe depressive disorders." For example, continued Dr. Thase, fewer than 50% of psychotherapists can provide cognitive-behavioral therapy or interpersonal therapy."This is where primary-care providers need to become more educated consumers," commented Dr. Susman. "When making a referral to a mental-health professional, we need to know that the counselor is trained in the specific therapies for which we have evidence of efficacy."
"We also need to ask counselors to keep us informed of a patient's progress and to keep track of their symptoms," added Dr. Thase.
"How good is the evidence for each of the psychotherapeutic interventions?" queried Dr. Salgo.
"Cognitive-behavioral therapy earns an A+ in terms of evidence-based medicine," summarized Dr. Thase.
"Interpersonal therapy gets an A, only because the evidence is based on a smaller number of studies. Problem-solving therapy earns a high B; there are relatively few but consistent studies showing it makes a difference."
Dr. Kroenke noted two challenges with nonpharmacological studies: "The first is getting them funded, and the second is devising the comparison protocol. For example, it is easy to give a patient a placebo that looks like an antidepressant; it is more difficult to give sham psychotherapy."
"Let's remember that drugs and psychotherapy are not interchangeable," cautioned Dr. Rosenbaum. "As the severity of depression goes up, the efficacy of psychotherapy as compared with that of pharmacological therapy goes down." Another important point, he continued, is that pharmacological therapy and psychotherapy address two different areas of patient wellness and are therefore truly complementary therapies. Citing a classic trial of antidepressants and psychotherapy in mild depression by Weissman and associates,[35] Dr. Rosenbaum explained that "the core symptoms of depression improve with antidepressant therapy and the quality-of-life measures improve with psychotherapy. So while the statistical improvement conferred by the two therapies may be comparable, they work by different mechanisms to address different components of the illness, arguing, I believe, for the advantage of combination therapy in patients who do not achieve remission with one therapy."
Dr. Thase cited the results of a pooled analysis he conducted with his colleagues in which "the combination of psychotherapy and pharmacotherapy made almost a three-fold difference in the chance of people getting to remission."
"We do not have many trials of psychotherapy that examine the duration of effect," pointed out Dr. Kroenke. "In the short term, pharmacological therapy may get people better quicker, but with psychotherapy, the question is, years down the line, will patients display the skills that will help them stay in remission?"
"The clear message is: do not stop treating," declared Dr. Culpepper. "If the patient is on pharmacotherapy and is not improving, the clinician needs to think about psychotherapy, and vice versa. And if a patient has undergone 12 weeks of psychotherapy and is still depressed, it is time to find a different form of psychotherapy or pharmacotherapy."
"With psychotherapy, if the patient is not doing better within two to three months, it is time to call in another option," agreed Dr. Krishnan.
Pharmacological Therapy
Approximately two-thirds of patients with depression will respond to antidepressant therapy, a proportion that has remained steady since the advent of drug therapy in the 1950s. With recent advances in neuroscience, however, has come the development of new antidepressants with targeted pharmacological properties.[36] Dr. Salgo asked the panelists to "lead us through the commonly used classes of antidepressant medications.""All of our currently available antidepressants are variations on a theme, and that theme is molecules that perturb the neurotransmitters in the brain — either norepinephrine or serotonin, or both," stated Dr. Rosenbaum.
Reviewing the history of antidepressants, he noted that the first available agents were tricyclic antidepressants (TCAs), which had "varying ratios of serotonin reuptake inhibition and norepinephrine reuptake inhibition, and MAO inhibitors, which influenced these neurotransmitters differently. These early drugs had significant adverse effects and safety issues," he noted.
"Over time," continued Dr. Rosenbaum, "the pharmaceutical industry developed agents that had similar mechanisms and targeted similar systems but were safer." Among these agents are the selective serotonin reuptake inhibitors (SSRIs) and the serotonin-noradrenaline reuptake inhibitors (SNRIs); the latter class, like the TCAs, have dual neurotransmitter activity. Other drug classes, like the tetracyclics, affect these systems somewhat differently, while the aminoketone drugs work by mechanisms that are not entirely clear but seem to circle around norepinephrine. "Added to this modern array of antidepressants are a few others that are less widely used," concluded Dr. Rosenbaum, "as well as new investigative drugs on the horizon."
"What evidence do we have on these agents in terms of complete remission versus simple improvement?" inquired Dr. Salgo.
As pointed out earlier in this Medical Crossfire, most efficacy studies of antidepressants use response, defined as a 50% reduction in baseline total HAM-D score, as the therapeutic benchmark, Dr. Rosenbaum pointed out. By this parameter, similar efficacy among the novel antidepressants has been generally reported, with improved safety and tolerability over the conventional agents.[37-40] Newer analyses, however, seem to indicate that there may be differences among the drug classes, explained Dr. Rosenbaum, "although there is the usual controversy about whether the methodologies of the individual trials are comparable."
Among these newer analyses, Dr. Rosenbaum cited some examples. "Data from two different studies in Denmark suggest that clomipramine, a potent dual-acting TCA, outperforms SSRIs.[41] Another unpublished study showed that the investigative dual-acting agent duloxetine confers higher remission rates than SSRIs." In fact, the new body of work focusing on remission rather than response seems to indicate that there are differences in outcome efficacy among the available agents, observed Dr. Rosenbaum. "For example, Dr. Thase recently published a metaanalysis[42] showing that for every 100 patients treated with the dual-acting SNRI venlafaxine rather than an SSRI, 10 additional patients will achieve remission."
Dr. Thase noted that a problem with many efficacy studies of antidepressants is that the numbers of patients enrolled "are too small to find the difference between a good treatment and a possibly better treatment. All of these treatments appear good; therefore, large numbers of patients are needed to reveal subtle distinctions in efficacy among the good and the better drugs." Metaanalyses of existing small studies allow researchers access to the larger populations necessary for comparison.
To that end, Dr. Thase and his colleagues[42] conducted a metaanalysis of eight comparable, randomized, double-blind studies of major depressive disorder to compare remission rates among 851 patients treated with the SNRI venlafaxine; 748 patients treated with the SSRIs fluoxetine, paroxetine, or fluvoxamine (the majority were treated with fluoxetine); and 446 patients treated with placebo. Remission was defined as achievement of a total HAM-D score of 7 or less. Remission rates were 45% in the venlafaxine group, 35% in the SSRI group, and 25% in the placebo group. The odds ratio was 1.5 in favor of venlafaxine versus SSRIs. The efficacy benefit of venlafaxine over SSRIs was seen at two weeks, whereas the efficacy benefit of SSRIs over placebo was seen at four weeks.
Commenting on this metaanalysis, Dr. Thase noted that "the results are variable across each individual study that was included, all doses for all patients for all comparisons cannot be proved, and the studies generally end at six or eight weeks. Therefore, evidence of long-term, sustained remission is not yet confirmed." He added that since the publication of this paper, the metaanalysis has been expanded to include 33 studies, "and the results continue to hold. These data were presented at this year's meeting of the American Psychiatric Association."
To Dr. Krishnan's point that, based on the data, 10 patients would need to be treated with venlafaxine to achieve one additional remission, Dr. Thase responded, "Venlafaxine is a lot more effective than placebo and definitely more effective than the SSRI. Achieving remission in one of 10 people is a choice clinicians would make."
"Efficacy studies utilize an optimal setting to ensure that the patient adheres to treatment and completes the study," observed Dr. Culpepper. "In primary care, we are looking for effectiveness, which takes into consideration the complications and less-than-optimal settings of real-world practice." Although the data from efficacy trials are, "nevertheless, very helpful," continued Dr. Culpepper, "additional data — for example, side effects and discontinuation rates — help to provide a translation of efficacy into effectiveness."
"In our study, 9% of patients on venlafaxine, 7% on SSRIs, and 1% on placebo dropped out due to intolerable side effects," offered Dr. Thase. The differences in side effect-associated dropout rates in the two active-drug groups as compared with the placebo group were statistically significant, although the difference in rates between the two active-drug groups was not. Because venlafaxine "has two mechanisms of action, it also has two mechanisms of side effects," continued Dr. Thase. "Patients treated with venlafaxine demonstrated more nausea and a few more of the norepinephrine-associated side effect complaints, for example, dry mouth and constipation. But venlafaxine is closer to an SSRI than to a TCA in tolerability."
"Were there also differences in onset of remission?" queried Dr. Salgo.
"In controlled trials of six to eight weeks, the average time to remission is somewhere between six and eight weeks," answered Dr. Thase. "In a trial of 16 or 18 weeks, the average time to remission is 12 to 14 weeks. So what you are looking for is the first glimmer of response, the response, and the remission. These should unfold in order about one to two weeks apart."
Dr. Rosenbaum pointed out that some agents, for example, fluoxetine, "may be associated with onset of remission beginning quite late, around 12 weeks. If the study ends at six or eight weeks, then the response rate may be high but the remission has been missed."
"The SSRIs and the TCAs are comparable in onset of action in broad clinical studies," commented Dr. Thase. "The TCAs may have an advantage in hospital-based studies where the dose can be pushed faster. In terms of SNRI versus SSRI, the only evidence base is the venlafaxine versus SSRI dataset, which showed a seven- to 10-day advantage with venlafaxine."
"Do we have any data about the safety of these agents over the long term?" asked Dr. Salgo.
"The long-term safety of all antidepressants looks very good, in part, of course, because patients who do not tolerate the medication do not take it over the long term," replied Dr. Rosenbaum, although "patients still struggle with issues like sexual dysfunction and weight gain, but that is not a safety issue, it is a quality of life issue."
"Are there differences in side effects among different patient populations?" questioned Dr. Salgo.
"Tolerability changes as people move from midlife into later life, so clinicians may need to consider reducing the dose as the patient ages," answered Dr. Thase. He also noted the concern that "these medicines will become habit forming and that there will be a continual need to increase the dose. This is not generally a big problem."
More than 50% of patients prescribed an antidepressant report stopping their medication or skipping doses due to side effects.[43] Noting this statistic, Dr. Salgo asked, "Working toward the goal of remission, what can be done to enhance compliance?"
"If there is to be any chance of compliance at all, the key is educating the patient and the family," emphasized Dr. Krishnan. The second critical point is consistent follow-up at periodic intervals, which, he noted, "is the only way to determine if the patient is taking the drug. And, third, the patient has to be willing to be treated. The patient who says, 'Taking a drug means I am a weak person,' is not going to comply with therapy."
"There also has to be a clear connection between the patient and the clinician," offered Dr. Rosenbaum. "The patient needs to feel that if he has a question, a concern, or a side effect, he can reach his physician. If the clinician tells the patient, 'Call me in three days and let me know how you feel. Call me whenever you have a question,' that patient is much more likely to feel that his clinician will respond to any anxieties about treatment."
Citing the work of Elizabeth Lin's group,[44] Dr. Kroenke suggested several messages that clinicians can share with their patients to increase the likelihood of compliance: "This medication is not habit forming. Take the medication every day. This pill will not bring you immediate relief, but the benefits will be gradual over several weeks. You may notice these side effects, but they will wane over time, and if they do not, I will change your medicine. If you are thinking about stopping the medication, call me first."
Alternative Medicine
Increasing interest in alternative therapies is reflected in the growing evidence base on the use of these agents for the treatment of depression and anxiety. "A lot of patients are using alternative therapies, for example, herbal remedies, to treat depressive disorders. But, in my estimation, these therapies have not demonstrated effectiveness," noted Dr. Susman."My reading of the literature is mixed on St. John's wort," commented Dr. Kroenke. While a recent metaanalysis of 22 randomized controlled trials found that St. John's wort was significantly more effective than placebo and comparable with antidepressants in the treatment of depression,[45] a recent 12-center, double-blind, randomized, placebo-controlled trial showed that St. John's wort was no better than placebo in treating moderately severe depression.[46]
"But in the latter study in which St. John's wort failed, so did the SSRI comparator. In fact, placebo looked very good in that study," countered Dr. Rosenbaum, who added that a recent single-site study demonstrated greater efficacy of St. John's wort as compared with an SSRI. He also described the use of SAMe, or S-adenosyl-methionine, in the treatment of depression as "very interesting. We studied this agent in the 1980s, and it very well may turn out to be a helpful adjunct for some patients."
"People with bad depression, however, need proven therapies," declared Dr. Susman.
"People view depression using a variety of different models, and one of these is more of a natural disharmony model that often includes an antimedical bias," added Dr. Thase. "For these individuals, trying the natural treatment makes sense. The key is that if it is not working, they need to move on."
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
Final Thoughts
"Depression is a disorder that reflects the dysregulation of the brain, and physicians should not think about treating this disorder any differently than they would think about treating a dysregulation of the heart," stated Dr. Rosenbaum in formulating his take-home message from this Medical Crossfire. "With depression, as with any other disease, predisposition and genetic factors interact with environmental triggers, threats, and stressors to set off a disorder that is comprehensively impairing across body, mind, and soul. But the good news is that depression responds to treatment. With persistent, aggressive treatment, we can improve the quality of life and the health status outcome of patients for the rest of their lives."
Dr. Kroenke focused his final thoughts on integrating evidence-based medicine into clinical practice. "Some practitioners think that evidence-based medicine means cookbook medicine — one formula for all patients. But cookbooks have many recipes with many ingredients; likewise, evidence-based medicine allows us to choose the best therapy for a specific patient from among a number of proven therapies." In addition, he concluded, clinicians can adapt evidence-based techniques to the realities of clinical practice "by looking outside the box of the 15-minute visit for creative solutions like telephone follow-up and patient self-monitoring."
"If clinicians keep in mind that depression has medical, social, and psychological consequences, we will be more conscientious about recognizing this disease and treating it adequately," declared Dr. Krishnan. For his part, Dr. Susman stated, "If I could change one thing in clinical practice for depression, it would be to improve patient follow-up to ensure that, whatever our choice of therapy, treatment is maintained." And Dr. Culpepper offered three final messages: "Use objective measures to evaluate improvement. Do not forget that hopelessness despite symptom improvement may identify patients at risk of suicide. And, finally, do not stop treatment until it succeeds."
"There are a range of effective treatments, both psychosocial and pharmacological, and these treatments display important differences as well as additive effects," concluded Dr. Thase. With multiple therapeutic strategies at hand, the clinician's charge should be, "If you recognize depression, treat it. If you treat it, treat it well. And when you treat it well, continue to treat for prevention."
Spotlight on Remission: Achieving an Evidence-Based Goal in Depression and Anxiety Disorders
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Evidence-Based Medicine and Psychiatric Care
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Faculty and DisclosuresAuthors
Sheetal Chhaya, DO (Reviewer)
Postgraduate Residency Fellow, Department of Medicine, University of Medicine & Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New JerseyDisclosure: Dr. Chhaya has no financial arrangements or affilliations to disclose.
Larry Culpepper, MD, MPH
Professor and Chairman, Department of Family Medicine, Boston University Medical Center, Chief, Family Practice, Boston Medical Center, Boston, MassachusettsDisclosure: Dr. Culpepper has been a consultant for Abbott Laboratories, Eli Lilly and Co., Forest Laboratories, Janssen Pharmaceutica, Pfizer, and Wyeth Pharmaceuticals.
Camille Horton, MD (Reviewer)
Postgraduate Residency Fellow, Department of Family Medicine, University of Medicine & Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New JerseyDisclosure: Dr. Horton has no financial arrangements or affilliations to disclose.
K. Ranga R. Krishnan, MB, ChB
Professor and Chair, Department of Psychiatry, Duke University Medical Center, Durham, North CarolinaDisclosure: Dr. Krishnan has received grant/research support from Eisai Pharmaceuticals, Forest Laboratories, Novartis Pharmaceuticals, and Pfizer; and has been a consultant for Abbott Laboratories, GlaxoSmithKline Pharmaceuticals, Merck & Co., Organon, Pfizer, Synaptic, Vela Pharmaceuticals, and Wyeth Pharmaceuticals.
Kurt Kroenke, MD
Professor of Medicine, Indiana University School of Medicine; Senior Research Scientist, Regenstrief Institute for Health Care, Indianapolis, IndianaDisclosure: Dr. Kroenke has received grant/research support from Eli Lilly and Co. and has been a consultant for Pfizer and Wyeth Pharmaceuticals.
Shanthi Lewis, MD (Reviewer)
Postgraduate Residency Fellow, Department of Psychiatry, University of Medicine & Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New JerseyDisclosure: Dr. Lewis has no financial arrangements or affilliations to disclose.
Matthew Menza, MD (CME Activity Director)
Vice-Chair and Chief, Division of Clinical Psychopharmacology, Department of Psychiatry, Associate Professor of Psychiatry & Neurology, University of Medicine & Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New JerseyDisclosure: Dr. Menza has received grant/research support from Bristol-Myers Squibb, Cephalon, Forest Laboratories, GlaxoSmithKline Pharmaceuticals, Eli Lilly and Co., Pfizer, Solvay Pharmaceuticals, and Wyeth Pharmaceuticals; has been a consultant for Bayer Corp., Bristol-Myers Squibb, Cephalon, Eli Lilly and Co., and Pfizer; and has served on the speakers' bureaus of Bristol-Myers Squibb, Cephalon, Eli Lilly and Co., and Pfizer.
Victoria Raiwe, MD (Reviewer)
Postgraduate Residency Fellow, Department of Psychiatry, University of Medicine & Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New JerseyDisclosure: Dr. Raiwe has no financial arrangements or affilliations to disclose.
Jerrold F. Rosenbaum, MD
Professor, Department of Psychiatry, Harvard Medical School, Cambridge, Massachusetts; Chief of Department, Department of Psychiatry, Massachusetts General Hospital, Boston, MassachusettsDisclosure: Dr. Rosenbaum has been a consultant for Cyberonics, Forest Laboratories, Eli Lilly and Co., Organon, and Wyeth Pharmaceuticals; and has served on the speakers' bureaus of Eli Lilly and Co., Forest Laboratories, and Wyeth Pharmaceuticals.
Peter L. Salgo, MD
Medical Correspondent, WCBS-Television, New York; Clinical Professor of Medicine and Anesthesiology, Columbia University College of Physicians and Surgeons, New York, New YorkDisclosure: Dr. Salgo has no financial arrangements or affiliations to disclose.
Jeffrey L. Susman, MD
Professor and Director, Department of Family Medicine, University of Cincinnati College of Medicine, Cincinnati, OhioDisclosure: Dr. Susman has been a consultant for and has served on the speakers' bureaus of Forest Laboratories, GlaxoSmithKline Pharmaceuticals, Organon, Pfizer, and Wyeth Pharmaceuticals.
Michael E. Thase, MD
Professor of Psychiatry, University of Pittsburgh School of Medicine; Chief, Division of Adult Academic Psychiatry, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.Disclosure: Dr. Thase has received grant/research support from Cyberonics, Pharmacia Corp., and Wyeth Pharmaceuticals; has been a consultant for Bristol-Myers Squibb, Cephalon, Cyberonics, Eli Lilly and Co., Forest Laboratories, GlaxoSmithKline Pharmaceuticals, Novartis Pharmaceuticals, Organon, Pfizer, Pharmacia Corp., and Wyeth Pharmaceuticals; and has served on the speakers' bureaus of Bristol-Myers Squibb, Eli Lilly and Co., Forest Laboratories, GlaxoSmithKline Pharmaceuticals, Organon, Pfizer, Pharmacia Corp., Solvay Pharmaceuticals, and Wyeth Pharmaceuticals.
Cindy Yeung, DO (Reviewer)
Postgraduate Residency Fellow, Department of Psychiatry, University of Medicine & Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New JerseyDisclosure: Dr. Yeung has no financial arrangements or affilliations to disclose.
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