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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 25, 2008

Keywords

ClinConnect Summary

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 individuals with the disorder, but functional impairment can occur even when bipolar disorder is in remission. Previous research indicates that this impairment in stable individuals with bipolar disorder is linked to neurocognitive deficits, such as problems with memory and attention. The drug extended release galantamine increases the level of acetylcholine, a neurotransmitter important for me...

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Eligibility 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