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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00106405
First received: March 24, 2005
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Bipolar Disorder
 Drug: Memantine HCl
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS)
  • Mania Rating Scale
  • Clinical Global Impression
  • Montgomery Asberg Depression Rating Scale
  • Positive and Negative Syndrome Scale (PANSS)
  • PANSS - Excited Component

Enrollment: 35
Study Start Date: February 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106405

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00106405     History of Changes
Other Study ID Numbers: MEM-MD-27
Study First Received: March 24, 2005
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Bipolar I Disorder
Mania
Memantine HCl

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013