A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
| Sponsors |
Lead Sponsor: Cambridge Health Alliance Collaborator: Northwestern University |
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| Source | 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. |
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| Detailed Description | The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings. |
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| Overall Status | Completed | ||||||
| Start Date | April 2003 | ||||||
| Completion Date | February 2007 | ||||||
| Primary Completion Date | September 2006 | ||||||
| Phase | Phase 4 | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Enrollment | 30 | ||||||
| Condition | |||||||
| Intervention |
Intervention Type: Drug Intervention Name: Galantamine Arm Group Label: Double-Blind Galantamine vs Placebo Intervention Type: Drug Intervention Name: Placebos Arm Group Label: Placebo Control Group |
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| Eligibility |
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: 60 Years Healthy Volunteers: Accepts Healthy Volunteers |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
April 2017 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||
| Condition Browse | |||||||
| Number Of Arms | 2 | ||||||
| Arm Group |
Label: Double-Blind Galantamine vs Placebo Type: Experimental Description: Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction Label: Placebo Control Group Type: Placebo Comparator Description: Placebo-Controlled Group |
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| Study Design Info |
Allocation: Randomized Intervention Model: Crossover Assignment Primary Purpose: Treatment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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