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

May 5, 2008 updated by: Memory Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Bipolar Disorder With Manic or Mixed Episodes

Intervention / Treatment

Drug: MEM 1003

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 of excessively elevated and/or irritable mood (mania). The pathophysiology of bipolar disorder is complex, and can include an inheritable component, administration of antidepressant medications, behavioral sensitization processes, and neuronal calcium dysregulation that leads to apoptosis of critical brain circuitry that regulates emotion. Addressing the dysregulation in calcium levels in the central nervous system by administering compounds such as MEM 1003 may have the potential for altering the cyclical course or progression of bipolar disorder.

MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72201
- California
  - Garden Grove, California, United States, 92845
  - Riverside, California, United States, 92506
  - San Diego, California, United States, 92105
  - Torrance, California, United States, 90502
- Florida
  - Bradenton, Florida, United States, 34208
  - Ft Lauderdale, Florida, United States, 33301
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
  - Shreveport, Louisiana, United States, 71101
- Massachusetts
  - Boston, Massachusetts, United States, 02114
- New Jersey
  - Willingboro, New Jersey, United States, 08046
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19149
- Texas
  - Austin, Texas, United States, 78756
  - Austin, Texas, United States, 78745
  - Austin, Texas, United States, 78729
  - Bellaire, Texas, United States, 77401
  - Dallas, Texas, United States, 75228
  - Houston, Texas, United States, 77008
  - Irving, Texas, United States, 75062
- Washington
  - Kirkland, Washington, United States, 98033
  - Kirkland, Washington, United States, 98034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate at Day 21

Secondary Outcome Measures

Outcome Measure
Change from baseline to Day 21 in other efficacy measures and safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memory Pharmaceuticals

Collaborators

Stanley Medical Research Institute

Investigators

Study Director: Stephen R Murray, MD, PhD, Memory Pharmaceuticals Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 9, 2006

First Submitted That Met QC Criteria

September 9, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MEM 1003-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.