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An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106405
Recruitment Status : Completed
First Posted : March 25, 2005
Last Update Posted : March 5, 2012
Information provided by:
Forest Laboratories

Brief Summary:
Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Memantine HCl Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Study Start Date : February 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Primary Outcome Measures :
  1. Young Mania Rating Scale (YMRS)
  2. Mania Rating Scale
  3. Clinical Global Impression
  4. Montgomery Asberg Depression Rating Scale
  5. Positive and Negative Syndrome Scale (PANSS)
  6. PANSS - Excited Component

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode.
  • Patients must be voluntarily hospitalized with a primary diagnosis of mania.

Exclusion Criteria:

  • Rapid cycling bipolar disorder.
  • Suicidal risk.
  • First manic episode.
  • ECT, clozapine or a depot neuroleptic in the past 3 months.
  • Substance dependence.
  • Known HIV infection.
  • Co-morbid serious, uncontrolled systemic illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106405

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United States, California
Synergy Clinical Research Center
National City, California, United States, 91950
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204
United States, Missouri
St. Charles Psychiatric Associates
St. Charles, Missouri, United States, 63301
United States, Ohio
Psychiatric Professional Services, Inc.
Cincinatti, Ohio, United States, 45267-0559
United States, Texas
Rebecca Sealy Hospital
Galveston, Texas, United States, 77555-0197
University Hills Clinical Research
Irving, Texas, United States, 75062
Sponsors and Collaborators
Forest Laboratories

Layout table for additonal information Identifier: NCT00106405    
Other Study ID Numbers: MEM-MD-27
First Posted: March 25, 2005    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by Forest Laboratories:
Bipolar I Disorder
Memantine HCl
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents