Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Galantamine-ER; Galantamine placebo
Intervention description: Galantamine-ER 8 to 24 mg per day for 16 weeks; Galantamine placebo 8 to 24 mg per day for 16 weeks
Intervention MeSH terms: Galantamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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