- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181636
Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder
April 23, 2007 updated by: Massachusetts General Hospital
The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar patients with stable mood.
This study is being done because a large proportion of patients with bipolar disorder experience significant memory problems, even when their mood is stable, after adequate treatment.
These memory problems have been associated with poor daily social functioning.
Studying galantamine-CR in this population may provide a new clinical way to combat memory problems in stable patients with bipolar disorder.
Study Overview
Study Type
Interventional
Enrollment
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- MGH Bipolar Clinic and Research Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV diagnostic criteria for bipolar disorder
- men or women aged 18-65
- a baseline Hamilton-D17 score of < 10 at screen visit
- a baseline YMRS score of < 10 at screen visit
- no acute episodes of depression or mania for the previous 12 weeks.
- written informed consent
Exclusion Criteria:
- Subjects with current suicidal ideation
- Pregnant women or women of childbearing potential
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months
- History of multiple adverse drug reactions
- Patients with mood congruent or mood incongruent psychotic features Subjects who are active smokers or who stopped smoking less than 3 months prior to enrollment; Clinical or laboratory evidence of hypothyroidism
- Patients who have had an episode of acute depression or mania during the 12 weeks prior to enrollment
- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment
- Patients with physical contraindications to magnetic resonance spectroscopy (ferrous surgical clips, cardiac pacemakers, ferrous prosthesis)
- Patients taking any of the following medications: other cholinesterase inhibitors, succinylcholine, neuromuscular blocking agents, cholinergic agonists (e.g., bethanechol), cimetidine, ketoconazole, erythromycin, fluoxetine, paroxetine, and fluvoxamine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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neurocognitive testing at last study visit (18 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
April 24, 2007
Last Update Submitted That Met QC Criteria
April 23, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Parasympathomimetics
- Galantamine
Other Study ID Numbers
- 2003P-000030/24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ProgenaBiomeRecruitingBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
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Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
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University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
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Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
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Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoActive, not recruitingBipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II DisorderBrazil
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Medical University of South CarolinaMilken InstituteCompletedBipolar Disorder | Bipolar I Disorder | Bipolar II DisorderUnited States
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Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
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Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
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Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
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Myriad Genetic Laboratories, Inc.University of MinnesotaCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
Clinical Trials on Galantamine-CR
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Columbia UniversityNational Institutes of Health (NIH); National Center for Advancing Translational...SuspendedMyocardial Infarction | Acute Coronary SyndromeUnited States
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Zimmer BiometCompletedOsteoarthritis | Total Knee ArthroplastyUnited States
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University of North Carolina, Chapel HillCompleted
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Centre for Addiction and Mental HealthCAMH FoundationActive, not recruitingMild Cognitive Impairment | Major Depressive Disorder | tDCS | Transcranial Direct Current Stimulation | Alzheimer's DementiaCanada
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Ewha Womans UniversityCompleted
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Region SkaneActive, not recruitingArthroplasty, Replacement, KneeSweden