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

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Placebos; Drug: Galantamine

• Registration Number: NCT00195845
• Lead Sponsor: Cambridge Health Alliance

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-09
• Study Completion: 2007-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Control Group	Placebos	Placebo-Controlled Group
Double-Blind Galantamine vs Placebo	Galantamine	Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction

Primary Outcome Measures

Name	Time	Method
Cognitive Function	6 Months

Trial Locations

Locations (1)

Cambridge Health Alliance; 🇺🇸 Cambridge, Massachusetts, United States