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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Bipolar Disorder

Treatments: Drug: Memantine HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106405

MEM-MD-27

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.