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NCT00195845 Clinical Trial

A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:
A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195845
Other study ID # CHA-IRB-0000/02/03
Secondary ID GAL-USA-T102
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated April 17, 2017
Start date April 2003
Est. completion date February 2007

Study information
Verified date April 2017
Source Cambridge Health Alliance
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if galantamine augmentaion improves cognition in euthymic bipolar patients. In addition, the effect of galantamine on clinical measures of functioning and psychopathology will also be assessed.

Description:

The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 2007
Est. primary completion date September 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS < 16; MADRS < 16

Exclusion Criteria:

- Current substance dependence; serious unstable medical conditions; active suicidal ideation; current DSM-IV for a major mood episodes; history of COPD, epilepsy, cardiac arrhythmia, and peptic ulcer disease; meet DSM-IV criteria for dementia

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Galantamine

• Placebos

Locations
Country Name City State
United States Cambridge Health Alliance Cambridge Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Cambridge Health Alliance Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cognitive Function 6 Months
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