Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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 same function in stable people with bipolar disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Massachusetts General Hospital; National Institute of Mental Health (NIMH)
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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