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Studies and Anxiety Stuff -- Willow and Thrud

Posted by Rick on December 17, 2001, at 17:10:52

In reply to Rick, Willow :anxiety stuff, posted by Thrud on December 17, 2001, at 8:46:57

I'd say it’s pretty much a tossup between Provigil and selegiline as a fatigue-fighter and alertness-maintainer. For me the edge definitely goes to Provigil because it helps my social anxiety and seems more predictable. And there are no MAOI –interactions with Effexor (or many other meds) to be concerned with, as would be the case with selegiline. (That said, using very-small selegiline doses probably eliminates almost all the risks. Celexa’s website even used to link to an article citing common co-prescription of low-dose selegiline and SSRI’s to Parkinson’s patients with apparent safety and only rare, mild cases of serotonin syndrome – even though Celexa’s own monograph contra-indicates the combo. I’d personally be hesitant to take chances.)

Now, if maintaining sexual function is a key issue, I’d give selegiline a hard look.

Provigil definitely can treat non-medication-induced fatigue of various types, and I’d imagine the same is true for selegiline. As far as Provigil, it can work within hours…or it might take up to 7-10 days to start helping…or it might seem to work for awhile and then poop out. If the latter happens, stick with it awhile longer; it’s very likely the wakefulness effect will come back. Incidentally, every two-four weeks I have a day where Provigil doesn’t seem to be doing the trick, but the next day things are usually back to normal. (I WOULD say this results from modafinil’s ability to occasionally induce its own metabolism, but my understanding was that this is unlikely to occur at lower doses.)

Below is some of the requested literature.


1. In the link below, go to the section entitled “Stimulant Augmentation in Depression.” (it’s the second article). This isn’t the full study, but it gives more detail than an abstract. (Interestingly, this small study cites success augmenting Celexa (citalopram) with modafinil, even though #3 suggests this doesn’t work well due to a metabolic interaction.)

2. In the following link, go to the letter to the editor, which describes a case of successful augmentation of Effexor by Provigil. (I suggest you right-click and “save as” to keep the entire pdf file. There are some other interesting articles in here as well.)

3. The following is a recap (probably a press release) on some studies of modafinil for treatment of AD-induced fatigue:

New Data Show PROVIGIL Reduces Fatigue and Sleepiness in Patients With Depression - Results from Two New Pilot Studies Are Reported at the American Psychiatric Association Meeting in New Orleans

WEST CHESTER, Pa., May 10, 2001 /PRNewswire/ -- Data from two new pilot studies show that PROVIGIL(R) (modafinil) Tablets [C-IV] reduces fatigue and sleepiness in people who are clinically depressed and who are partial responders to antidepressant therapy.

Data from one study were presented on May 9 in a symposium at the annual meeting of the American Psychiatric Association (APA) in New Orleans. This study was a six-week pilot, double-blind, randomized study among 136 patients with major depressive disorder, who were partially responsive to their current antidepressant treatment. Study participants received between 100 mg and 400 mg of PROVIGIL daily. The most common side effects potentially attributable to PROVIGIL treatment included headache and nervousness.

Results of the study indicated that patients receiving PROVIGIL plus antidepressant treatment -- as compared to patients on antidepressant treatment plus placebo -- achieved statistically significant reductions (p< 0.05) in fatigue, as measured by the Fatigue Severity Scale, and in sleepiness, as measured by the Epworth Sleepiness Scale.

Statistically significant improvements (p< 0.05) in energy and concentration as measured by a sub-scale of the Hamilton Depression Scale (HAM-D retardation scale) were seen in patients taking PROVIGIL and various antidepressants including Prozac(R) (fluoxetine HCl), Zoloft(R) (sertraline HCl), or Paxil(R) (paroxetine HCl) but as anticipated, not in patients taking Celexa(TM), (citalopram HBr), a compound with which PROVIGIL has a known metabolic interaction. Results on the overall Hamilton Depression Scale (HAM-D 1-21), which contains elements that are not influenced by fatigue and cognitive function, did not distinguish PROVIGIL from placebo.

"Fatigue is a significant component of depression and a major problem in this patient population," reported Karl Doghramji, M.D., associate professor, department of psychiatry and human behavior at Jefferson Medical College of Thomas Jefferson University and Director, Sleep Disorders Center, Thomas Jefferson University Hospital, Philadelphia, one of the investigators in the multi-center study. "This study demonstrates that this medication may help the approximately 80 percent of patients that continue to experience fatigue and sleepiness associated with their depression."

This is the second pilot study to demonstrate the positive effects of PROVIGIL treatment on the symptom of fatigue. The first study in patients with Multiple Sclerosis related fatigue was presented last year at the American Academy of Neurology.

Investigator-Initiated Study

In a separate pilot study presented at a poster session at the APA meeting by Dr. Charles DeBattista of Stanford University, PROVIGIL was shown to significantly reduce fatigue in patients with depression. In the four-week, prospective, open-label study of 24 adults with major depressive disorder who were being treated with antidepressant therapy, patients treated with PROVIGIL demonstrated significant reductions in fatigue, as measured by the Fatigue Symptom Inventory and Fatigue Analog Scale. Improvements in cognition were also observed, particularly in concentration. Benefits were observed within two weeks of the start of therapy, and PROVIGIL was shown to be well tolerated in combination with a variety of antidepressants. The most reported side

effect was headache.


Depression is a serious illness that affects more than 19 million American adults, according to the National Institutes of Mental Health. Fatigue is one of the most common complaints in depressed patients. Sleep complaints are also common, with approximately 20 percent of patients suffering from excessive sleepiness. These symptoms are often exacerbated by current treatments, since adverse events associated with many antidepressant therapies include hypersomnia and fatigue.

PROVIGIL is a novel, wake-promoting agent currently approved in several countries for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy. The most common side effects associated with PROVIGIL in treating EDS associated with narcolepsy include nausea, infection, nervousness, anxiety and insomnia.

Cephalon, Inc., (Nasdaq: CEPH) markets PROVIGIL in the United States, the United Kingdom, Ireland, and Italy and promotes the product in Austria and Switzerland under the brand name MODASOMIL(R). In addition, Cephalon holds exclusive marketing and distribution rights to PROVIGIL in Japan, South Korea, Taiwan and Latin America.

Cephalon, Inc., headquartered in West Chester, Pennsylvania, is an international biopharmaceutical company dedicated to the discovery, development and marketing of products to treat sleep and neurological disorders, cancer and pain.




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