A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
This trial is active, not recruiting.
|Sponsor||Cambridge Health Alliance|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
Male or female participants from 18 years up to 60 years old.
- Age 18-60; DSM-IV diagnosis of bipolar disorder, any subtype; Baseline Mini Mental Status exam above 20; MRS < 16; MADRS < 16
- 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
|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.|
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