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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Memory Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00374920
First received: September 9, 2006
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder With Manic or Mixed Episodes
Drug: MEM 1003
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memory Pharmaceuticals:

Primary Outcome Measures:
  • Response rate at Day 21

Secondary Outcome Measures:
  • Change from baseline to Day 21 in other efficacy measures and safety

Estimated Enrollment: 60
Study Start Date: September 2006
Study Completion Date: March 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374920

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72201
United States, California
Garden Grove, California, United States, 92845
Riverside, California, United States, 92506
San Diego, California, United States, 92105
Torrance, California, United States, 90502
United States, Florida
Bradenton, Florida, United States, 34208
Ft Lauderdale, Florida, United States, 33301
United States, Louisiana
Lake Charles, Louisiana, United States, 70601
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, New Jersey
Willingboro, New Jersey, United States, 08046
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19149
United States, Texas
Austin, Texas, United States, 78729
Austin, Texas, United States, 78745
Austin, Texas, United States, 78756
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75228
Houston, Texas, United States, 77008
Irving, Texas, United States, 75062
United States, Washington
Kirkland, Washington, United States, 98034
Kirkland, Washington, United States, 98033
Sponsors and Collaborators
Memory Pharmaceuticals
Stanley Medical Research Institute
Investigators
Study Director: Stephen R Murray, MD, PhD Memory Pharmaceuticals Corp
  More Information

No publications provided

Responsible Party: Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00374920     History of Changes
Other Study ID Numbers: MEM 1003-101
Study First Received: September 9, 2006
Last Updated: May 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memory Pharmaceuticals:
bipolar
mania
mixed

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014