Status:
COMPLETED
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00106405
Start Date
February 1 2005
End Date
November 1 2005
Last Update
March 5 2012
Active Locations (6)
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1
Synergy Clinical Research Center
National City, California, United States, 91950
2
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204
3
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States, 63301
4
Psychiatric Professional Services, Inc.
Cincinnati, Ohio, United States, 45267-0559