Status:
COMPLETED
Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will examine whether extended release galantamine, a drug approved by the Food and Drug Administration to reduce cognitive impairments in people with Alzheimer's disease, can perform the sa...
Detailed Description
Approximately 2.6% of Americans age 18 and older, or 5.7 million people, suffer from bipolar disorder. The manic and depressive episodes associated with bipolar disorder prevent normal functioning in ...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of Bipolar I disorder or Bipolar II disorder
- A baseline Hamilton-D 17 score of less than 10 at screening visit
- A baseline Young Mania Rating Scale (YMRS) score of less than 10 at screening visit
- No acute episodes of depression or mania for the previous 12 weeks
- Score of 17 or higher on the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire
- Treated with psychiatric medications, alone or in combination, having only minimal, mild or moderate cognitive burden \[as determined by a score of less than 3.5 on the MGH Cognitive Impact of Psychotropic Medications Scale (CIPMS).
- Able to understand English
Exclusion
- DSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.
- Meets DSM-IV criteria for acute manic, depressive, or mixed bipolar episode or had met full criteria for 2 consecutive weeks within the past 12 weeks prior to assessment
- Treated with psychiatric medications with large effects on cognition (as determined by a MGH Cognitive Impact of Psychotropic Medications Scale score of 4.0 or above)
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
- Serious suicide or homicide risk
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- History of seizure disorder, brain injury, or any known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
- The following DSM-IV diagnoses: 1) organic mental disorders; 2) any diagnosis of dementia; 3) substance use disorders, including alcohol, active within the last year; 4) schizophrenia; 5) delusional disorder; 6) psychotic disorders not elsewhere classified; 7) schizoaffective disorder; 8) major depressive disorder; 9) acute bereavement; 10) severe borderline or antisocial personality disorder
- Presence of mood congruent or mood incongruent psychotic features
- Clinical or laboratory evidence of hypothyroidism
- History of multiple adverse drug reactions, allergy to galantamine or other AChEIs
- Current use, or use within the last week, of excluded drugs (psychotropic medications and other central nervous system (CNS)-active drugs)
- Taken an investigational psychotropic drug within the last year
- Had electroconvulsive therapy (ECT) within the 6 months preceding enrollment
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00741598
Start Date
September 1 2008
End Date
May 1 2014
Last Update
May 2 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029