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Clinical Trials/NCT00106405
NCT00106405
Completed
Phase 2

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

Forest Laboratories6 sites in 1 country35 target enrollmentFebruary 2005
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ConditionsBipolar Disorder
DrugsMemantine HCl

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
Forest Laboratories
Enrollment
35
Locations
6
Primary Endpoint
Young Mania Rating Scale (YMRS)
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
November 2005
Last Updated
14 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Forest Laboratories

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (6)

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