An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00106405

First received: March 24, 2005

Last updated: March 1, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 24, 2005
Last Updated Date	March 1, 2012
Start Date ^ICMJE	February 2005
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00106405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Official Title ^ICMJE	A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Bipolar Disorder
Intervention ^ICMJE	Drug: Memantine HCl
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	35
Completion Date	November 2005
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00106405
Other Study ID Numbers ^ICMJE	MEM-MD-27
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Forest Laboratories
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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