Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder
A Multicenter, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 1003 for the Treatment of Patients With Bipolar I Disorder Suffering Acute Manic or Mixed Episodes
1 other identifier
interventional
60
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2006
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 9, 2006
CompletedFirst Posted
Study publicly available on registry
September 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMay 6, 2008
May 1, 2008
3 months
September 9, 2006
May 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate at Day 21
Secondary Outcomes (1)
Change from baseline to Day 21 in other efficacy measures and safety
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memory Pharmaceuticalslead
- Stanley Medical Research Institutecollaborator
Study Sites (21)
Unknown Facility
Little Rock, Arkansas, 72201, United States
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
Riverside, California, 92506, United States
Unknown Facility
San Diego, California, 92105, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Bradenton, Florida, 34208, United States
Unknown Facility
Fort Lauderdale, Florida, 33301, United States
Unknown Facility
Lake Charles, Louisiana, 70601, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Willingboro, New Jersey, 08046, United States
Unknown Facility
Philadelphia, Pennsylvania, 19149, United States
Unknown Facility
Austin, Texas, 78729, United States
Unknown Facility
Austin, Texas, 78745, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
Bellaire, Texas, 77401, United States
Unknown Facility
Dallas, Texas, 75228, United States
Unknown Facility
Houston, Texas, 77008, United States
Unknown Facility
Irving, Texas, 75062, United States
Unknown Facility
Kirkland, Washington, 98033, United States
Unknown Facility
Kirkland, Washington, 98034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen R Murray, MD, PhD
Memory Pharmaceuticals Corp
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2006
First Posted
September 12, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2006
Study Completion
March 1, 2007
Last Updated
May 6, 2008
Record last verified: 2008-05