Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memory Pharmaceuticals
• Collaborator: Stanley Medical Research Institute

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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