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Re: My letter to the FDA

Posted by detroitpistons on March 18, 2010, at 1:03:09

In reply to Re: My letter to the FDA, posted by SLS on March 18, 2010, at 0:25:09

This is encouraging. I know that there are researchers out there who take this issue seriously, but whether this research will be applied in the field is yet to be seen. Right now, all we have is each other......


> > The SSRI discontinuation syndrome is no longer completely ignored. Studies are being designed to explore the phenomenon more closely. Recently, a study of SSRI discontinuation syndrome using paroxetine and fMRI demonstrated a set of functional differences in brain activity during symptomatic episodes. The syndrome is now recognized by science, although it may not be by all clinical practitioners. Drug companies know about this stuff. I imagine they would rather not call any attention to it. Hopefully, letters to the FDA will not fall upon deaf ears. I just hope that the populace does not use the existence of this discontinuation syndrome to further fuel the backlash against antidepressants in general. We still need these drugs.
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> Here are two studies indicating significant changes in brain function associated with the emergence of SRI drug discontinuation symptoms. It is interesting that a DS rating scale has been devised.
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> These studies might prove useful in demonstrating a physiological basis for DS to addressees of petition letters.
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> - Scott
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> Biol Psychiatry. 2003 Jan 1;53(1):100-5.
> Cerebral blood volume and clinical changes on the third day of placebo substitution for SSRI treatment.
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> Henry ME, Kaufman MJ, Hennen J, Michelson D, Schmidt ME, Stoddard E, Vukovic AJ, Barreira PJ, Cohen BM, Renshaw PF.
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> Brain Imaging Center, McLean Hospital and Department of Psychiatry, Harvard Medical School, Belmont, Massachusetts 02478, USA.
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> BACKGROUND: Interruptions in SSRI treatment have been associated with adverse effects that can resemble depressive illness. We hypothesized that brain regions implicated in depression, with extensive serotonergic innervation, would exhibit changes in activity associated with emergence of symptoms following drug discontinuation. METHODS: Subjects meeting DSM-IV criteria for remitted major depression on 20 mg/day of either fluoxetine or paroxetine were recruited into this 6-week study. During weeks 2 and 6, subjects underwent a 3-day period in which either active drug or placebo was substituted for their medication under double-blind conditions. Cerebral blood volume (CBV) maps were obtained via dynamic susceptibility magnetic resonance imaging at the end of each double-blind period. RESULTS: In the paroxetine group, change in CBV in left medial superior frontal region and left caudate nucleus correlated significantly with change in Discontinuation Emergent Symptom Scale and Hamilton Depression Rating Scale (HDRS; R2 = 0.66, p =.0007; R2 = 0.51, p =.006; and R2 = 0.43, p =.015; R2 = 0.32, p =.043, respectively). CONCLUSIONS: These data demonstrate that changes in regional CBV of left prefrontal cortex and left caudate nucleus correlate with the emergence of discontinuation symptoms and increased HDRS after interruption of paroxetine treatment.
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> Biol Psychiatry. 2003 Sep 1;54(5):534-9.
> Selective serotonin reuptake inhibitor discontinuation syndrome is associated with a rostral anterior cingulate choline metabolite decrease: a proton magnetic resonance spectroscopic imaging study.
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> Kaufman MJ, Henry ME, Frederick B, Hennen J, Villafuerte RA, Stoddard EP, Schmidt ME, Cohen BM, Renshaw PF.
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> Brain Imaging Center, McLean Hospital, Harvard Medical School, Belmont, Massachusetts 02478, USA.
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> The selective serotonin reuptake inhibitor (SSRI) discontinuation syndrome (DS) is an important potential complication of treatment for major depression. We hypothesized that SSRI treatment discontinuation, resulting in change in clinical state, would be associated with reduced rostral anterior cingulate choline (Cho) metabolite ratios. Individuals with a DSM-III-R diagnosis of unipolar major depression who had been stabilized on paroxetine (n = 13) or fluoxetine (n = 13) were study subjects. They were monitored for change in clinical state (mood ratings, discontinuation symptoms) and underwent proton magnetic resonance spectroscopic imaging of the rostral anterior cingulate 3 days after medication substitution with active SSRI and placebo.Placebo-day Cho/Cre (choline/total creatine) metabolite ratios were decreased in four paroxetine and two fluoxetine subjects meeting DS criteria, as compared with asymptomatic subjects (Mann-Whitney z = -2.31, p =.021). Discontinuation syndrome is associated with a rostral anterior cingulate Cho/Cre metabolite ratio decrease that may reflect dynamics of rostral anterior cingulate function.
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> PMID: 12946882 [PubMed - indexed for MEDLINE]


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poster:detroitpistons thread:939283
URL: http://www.dr-bob.org/babble/20100305/msgs/939897.html