A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Sponsors
Source
Cambridge Health Alliance
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2003-04-01
Completion Date
2007-02-01
Primary Completion Date
2006-09-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Cognitive Function |
6 Months |
Enrollment
30
Condition
Intervention
Intervention Type
Drug
Intervention Name
Arm Group Label
Double-Blind Galantamine vs Placebo
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
Overall Official
Last Name |
Role |
Affiliation |
|
Robert T Dunn, MD, PhD |
Principal Investigator |
Cambridge Health Alliance |
Location
Facility |
|
Cambridge Health Alliance Cambridge Massachusetts 02139 United States |
Location Countries
Country
United States
Verification Date
2017-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Secondary Id
GAL-USA-T102
Number Of Arms
2
Intervention Browse
Mesh Term
Galantamine
Arm Group
Arm Group Label
Double-Blind Galantamine vs Placebo
Arm Group Type
Experimental
Description
Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction
Arm Group Label
Placebo Control Group
Arm Group Type
Placebo Comparator
Description
Placebo-Controlled Group
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
September 12, 2005
Study First Submitted Qc
September 12, 2005
Study First Posted
September 20, 2005
Last Update Submitted
April 17, 2017
Last Update Submitted Qc
April 17, 2017
Last Update Posted
April 18, 2017
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.