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A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195845
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Galantamine Drug: Placebos Phase 4

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4 Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
Study Start Date : April 2003
Actual Primary Completion Date : September 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Double-Blind Galantamine vs Placebo
Double-Blinded, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction
Drug: Galantamine
Placebo Comparator: Placebo Control Group
Placebo-Controlled Group
Drug: Placebos



Primary Outcome Measures :
  1. Cognitive Function [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195845


Locations
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United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
Northwestern University
Investigators
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Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance

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Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00195845    
Other Study ID Numbers: CHA-IRB-0000/02/03
GAL-USA-T102
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Bipolar Disorder
Cognitive Dysfunction
Bipolar and Related Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents