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Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Galantamine-CR
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MGH Bipolar Clinic and Research Program

Outcomes

Primary Outcome Measures

neurocognitive testing at last study visit (18 weeks)

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
April 23, 2007
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00181636
Brief Title
Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Galantamine-CR
Primary Outcome Measure Information:
Title
neurocognitive testing at last study visit (18 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan V Iosifescu, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Bipolar Clinic and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19889129
Citation
Iosifescu DV, Moore CM, Deckersbach T, Tilley CA, Ostacher MJ, Sachs GS, Nierenberg AA. Galantamine-ER for cognitive dysfunction in bipolar disorder and correlation with hippocampal neuronal viability: a proof-of-concept study. CNS Neurosci Ther. 2009 Winter;15(4):309-19. doi: 10.1111/j.1755-5949.2009.00090.x.
Results Reference
derived

Learn more about this trial

Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder

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