This trial is active, not recruiting.

Condition bipolar disorder
Treatment galantamine
Phase phase 4
Sponsor Cambridge Health Alliance
Collaborator Northwestern University
Start date April 2003
End date September 2005
Trial size 30 participants
Trial identifier NCT00195845, GAL-USA-T102


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Cognitive Function
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Principal investigator Robert T Dunn, MD, PhD
Description The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings. Reimbursement is $20 a visit and $50 each testing.
Trial information was received from ClinicalTrials.gov and was last updated in March 2006.
Information provided to ClinicalTrials.gov by Cambridge Health Alliance.