Overview

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