An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
1 other identifier
interventional
35
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2005
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 24, 2005
CompletedFirst Posted
Study publicly available on registry
March 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedMarch 5, 2012
March 1, 2012
9 months
March 24, 2005
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Synergy Clinical Research Center
National City, California, 91950, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21204, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301, United States
Psychiatric Professional Services, Inc.
Cincinnati, Ohio, 45267-0559, United States
Rebecca Sealy Hospital
Galveston, Texas, 77555-0197, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2005
First Posted
March 25, 2005
Study Start
February 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
March 5, 2012
Record last verified: 2012-03