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

Cambridge Health Alliance

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Galantamine; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT00195845

CHA-IRB-0000/02/03

GAL-USA-T102

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Double-Blind Galantamine vs Placebo

Experimental group

Description:

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

Treatment:

Drug: Galantamine

Placebo Control Group

Placebo Comparator group

Description:

Placebo-Controlled Group

Treatment:

Drug: Placebos