Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

2003P-000030/24


NCT ID:

NCT00181636


Secondary ID:


Study Acronym:


Brief Title:

Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:


Overall Contact Information

Official Name:Dan V Iosifescu, MD
Principal Investigator
Massachusetts General Hospital

Study Dates

Completion Date:October 2006
Completion Type:Actual
Verification Date:April 2007
Last Changed Date:April 23, 2007
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:neurocognitive testing at last study visit (18 weeks)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Galantamine-CR

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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