Status:
COMPLETED
Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 stab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00181636
End Date
October 1 2006
Last Update
April 24 2007
Active Locations (1)
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1
MGH Bipolar Clinic and Research Program
Boston, Massachusetts, United States, 02114