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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Memantine

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.