An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Completed · Phase 2
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT00106405
- Run by
- Forest Laboratories
- People needed
- 35
- Starts
- 2005-02-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2012-03-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Synergy Clinical Research Center — National City, California, United States
- Sheppard Pratt Health System — Baltimore, Maryland, United States
- St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
- Psychiatric Professional Services, Inc. — Cincinnati, Ohio, United States
- Rebecca Sealy Hospital — Galveston, Texas, United States
- University Hills Clinical Research — Irving, Texas, United States
Full record on ClinicalTrials.gov
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