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investigational drug Saredutant

Posted by River1924 on May 8, 2006, at 0:28:35

Hello,

I always find the reasons to exclude people from medication trials bizarre. To me, it seems these criteria (listed below) exclude a majority of the people who really need meds. I came across these points for the investigational drug Saredutant succinate (SR48968C). This is a Phase III trial. It is a fairly common list. (It doesn't include, thank god, the one that bumps me off most med trials... being overweight.) Shouldn't the medications trials try to include people with serious mental health problems. To me, it seems they exclude people who really need help.

Number 7 in this list is even more bizarre since this med works in an entirely different way from current meds.

• 1.Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
• 2.The duration of the current depressive episode is greater than 2 years.
• 3.Patients who are currently suicidal or have a history of a suicide attempt within 3 years prior to entry.
• 4.Patients whose current depressive episode is secondary to a general medical disorder.
• 5.Patients with a history or presence of bipolar disorders or psychotic disorders according to the D and L criteria of the MINI.
• 6.Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
• 7.Patients with a history of failure to respond to treatment with paroxetine or other antidepressant medications.

Are there really that many people left?

River.


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poster:River1924 thread:641187
URL: http://www.dr-bob.org/babble/20060504/msgs/641187.html