An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00106405
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
St. Charles Psychiatric Associates
🇺🇸St. Charles, Missouri, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Rebecca Sealy Hospital
🇺🇸Galveston, Texas, United States
Psychiatric Professional Services, Inc.
🇺🇸Cincinatti, Ohio, United States
University Hills Clinical Research
🇺🇸Irving, Texas, United States