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

NCT ID: NCT00374920

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar Disorder With Manic or Mixed Episodes

Keywords

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bipolar mania mixed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MEM 1003

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Memory Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Memory Pharmaceuticals Corp.

Principal Investigators

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Stephen R Murray, MD, PhD

Role: STUDY_DIRECTOR

Memory Pharmaceuticals Corp

Locations

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Little Rock, Arkansas, United States

Site Status

Garden Grove, California, United States

Site Status

Riverside, California, United States

Site Status

San Diego, California, United States

Site Status

Torrance, California, United States

Site Status

Bradenton, Florida, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Lake Charles, Louisiana, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Boston, Massachusetts, United States

Site Status

Willingboro, New Jersey, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Austin, Texas, United States

Site Status

Austin, Texas, United States

Site Status

Austin, Texas, United States

Site Status

Bellaire, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Irving, Texas, United States

Site Status

Kirkland, Washington, United States

Site Status

Kirkland, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MEM 1003-101

Identifier Type: -

Identifier Source: org_study_id