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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Double-Blind Galantamine vs Placebo

Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction

Group Type EXPERIMENTAL

Galantamine

Intervention Type DRUG

Placebo Control Group

Placebo-Controlled Group

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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Galantamine

Intervention Type DRUG

Placebos

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes