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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Memantine HCl

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No