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Question for Dr. Dave

Posted by moxy1000 on September 27, 2002, at 16:52:41

In reply to re efficacy and s/e Anyuser, posted by IsoM on September 27, 2002, at 16:08:33

Dr. Dave,

I have a question regarding the design of most studies done by drug companies to evaluate the efficacy of anti-depressants. Most study designs evaluate moderate-severe patients (as determined by widely used rating scales), diagnosed with major depression. However, the study designs don't include patients with mild depression or patients with comorbidities.

My question is why do you think these types of patients are excluded from most clinical trials?

I've heard conflicting theories. The first is that many believe if an anti-depressant works for moderate or severe depressed patients, it would be logical to assume that it would work for the milder, easier to treat patients as well. Conversely, I've heard that drug companies are "scared" to evaluate mild depression, because they are fearful that placebo would work as well as the active agent, if not better.

I tend to agree with the first statement, because even if placebo worked better then an active agent, the depression could not have been that debilitating to begin with. It would seem that for many patients, several things other then "placebo-affect" would have a positive impact on depression. Simply the desire to want to feel better, and the constant attention given to patients by clinicians involved in studies, would seem like it would help in improving depressive symptoms.

Anyway, just a question that's been rattling around in my brain for awhile, and I thought I'd get your take on it.

Thanks!


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poster:moxy1000 thread:109458
URL: http://www.dr-bob.org/babble/20020922/msgs/121270.html