Status:
COMPLETED
Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder
Lead Sponsor:
Memory Pharmaceuticals
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder With Manic or Mixed Episodes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to establish the potential of MEM 1003 as a safe and effective treatment for patients with an acute manic or mixed episode of bipolar disorder.
Detailed Description
Bipolar affective disorder is one of the most common, severe, and persistent mental illnesses. It is characterized by periods of deep, prolonged, and profound depressions that alternate with periods o...
Eligibility Criteria
Inclusion
- bipolar I disorder with acute manic or mixed episode, with or without psychotic features
- YMRS score of at least 20
- history of at least one previous manic or mixed episode requiring treatment in the last 10 years
Exclusion
- history of failing to respond to treatment with two or more adequate trials of approved anti-manic medications for the current episode
- Axis I or Axis II disorder (other than bipolar I disorder) that requires treatment or has been the primary subject of treatment in the past 3 months
- defined substance abuse or dependency within the 3 months
- schizophrenia, schizoaffective disorder, delusional disorder, mental retardation or pervasive developmental disorder
- suicidal or danger to others
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00374920
Start Date
September 1 2006
End Date
March 1 2007
Last Update
May 6 2008
Active Locations (21)
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1
Little Rock, Arkansas, United States, 72201
2
Garden Grove, California, United States, 92845
3
Riverside, California, United States, 92506
4
San Diego, California, United States, 92105