Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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: 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
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014