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

Completed · Phase 2

Conditions studied: Bipolar Disorder With Manic or Mixed Episodes

In brief

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.

Key facts

Study ID

NCT00374920

Run by

Memory Pharmaceuticals

People needed

60

Starts

2006-09-01

Expected to finish

2007-03-01

Last updated by the study team

2008-05-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Garden Grove, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Willingboro, New Jersey, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Bellaire, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Irving, Texas, United States
• Study site — Kirkland, Washington, United States
• Study site — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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