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

March 1, 2012 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

March 24, 2005

First Submitted That Met QC Criteria

March 24, 2005

First Posted (Estimate)

March 25, 2005

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-MD-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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