Overview

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.