![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 4 of 4. This is the beginning of the thread.
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.
Posted by linkadge on May 8, 2006, at 16:33:08
In reply to investigational drug Saredutant, posted by River1924 on May 8, 2006, at 0:28:35
D'you know the purported mechanisms of this drug ?
Linkadge
Posted by Phillipa on May 8, 2006, at 18:59:03
In reply to investigational drug Saredutant, posted by River1924 on May 8, 2006, at 0:28:35
Nope. Love Phillipa
Posted by trumpet on June 5, 2006, at 14:15:18
In reply to investigational drug Saredutant, posted by River1924 on May 8, 2006, at 0:28:35
Yes, I do find it frustrating about the criteria. I just received word from cncgordon (username) that the Saredutant trial is almost complete. If you have questions I'm sure he would be willing to answer them. I hope this drug works. I'm one who can't afford to stop my meds and risk a placebo. I have had success with the SSRI's in the past but my main symptom now is anxiety constant. Anyway let's keep this thread going.
Sincerely,
David
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.