Back to resultsA Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Galantamine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
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
Sites / Locations
- Cambridge Health Alliance
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Double-Blind Galantamine vs Placebo
Placebo Control Group
Arm Description
Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction
Placebo-Controlled Group
Outcomes
Primary Outcome Measures
Cognitive Function
Secondary Outcome Measures
Full Information
NCT ID
NCT00195845
First Posted
September 12, 2005
Last Updated
April 17, 2017
Sponsor
Cambridge Health Alliance
Collaborators
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00195845
Brief Title
A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Official Title
A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study length is 12 to 24 weeks depending on whether patients enter the crossover. Study also involves 3 neuropsychology testings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double-Blind Galantamine vs Placebo
Arm Type
Experimental
Arm Description
Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction
Arm Title
Placebo Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo-Controlled Group
Intervention Type
Drug
Intervention Name(s)
Galantamine
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Cognitive Function
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Dunn, MD, PhD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
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