Back to resultsAn Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Memantine HCl
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder, Mania, Memantine HCl
Eligibility Criteria
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.
Sites / Locations
- Synergy Clinical Research Center
- Sheppard Pratt Health System
- St. Charles Psychiatric Associates
- Psychiatric Professional Services, Inc.
- Rebecca Sealy Hospital
- University Hills Clinical Research
Outcomes
Primary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00106405
Brief Title
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Official Title
A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I Disorder, Mania, Memantine HCl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Memantine HCl
Primary Outcome Measure Information:
Title
Young Mania Rating Scale (YMRS)
Title
Mania Rating Scale
Title
Clinical Global Impression
Title
Montgomery Asberg Depression Rating Scale
Title
Positive and Negative Syndrome Scale (PANSS)
Title
PANSS - Excited Component
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
St. Charles Psychiatric Associates
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Psychiatric Professional Services, Inc.
City
Cincinatti
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Rebecca Sealy Hospital
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0197
Country
United States
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
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