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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106405
• Other study ID #: MEM-MD-27
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2005
• Last updated: March 1, 2012
• Start date: February 2005
• Est. completion date: November 2005

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Memantine HCl

Locations

Country	Name	City	State
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Psychiatric Professional Services, Inc.	Cincinatti	Ohio
United States	Rebecca Sealy Hospital	Galveston	Texas
United States	University Hills Clinical Research	Irving	Texas
United States	Synergy Clinical Research Center	National City	California
United States	St. Charles Psychiatric Associates	St. Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale (YMRS)
Primary	Mania Rating Scale
Primary	Clinical Global Impression
Primary	Montgomery Asberg Depression Rating Scale
Primary	Positive and Negative Syndrome Scale (PANSS)
Primary	PANSS - Excited Component