Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

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.
    

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 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 memory, available in the brain. This drug has
      already been approved by the FDA to treat neurocognitive impairment in Alzheimer's disease
      patients. This study will examine whether administering the drug to individuals with bipolar
      disorder who are in remission can also reduce their neurocognitive deficits and improve the
      quality of their life. The study will also examine the safety of the drug for use in the
      obsessive-compulsive disorder population.

      Participation in this study will last about 18 weeks and will involve six study visits. Each
      of the first two visits will include 2 hours of clinical, physical, and self-report tests,
      the first for screening and the second to establish physical and mental health baseline
      measurements. Participants will then be randomly assigned to receive either galantamine or
      placebo daily for 16 weeks, and they will be provided with enough of the assigned pill to
      last until the next visit. Half hour visits on Weeks 4, 8, and 12 will consist of
      psychological self-report tests and interviews, clinical assessment of side effects from the
      drug, and the determination by the examining doctor and participant whether to increase,
      decrease, or maintain the same level of the drug. Participants will also be given enough of
      the drug to last until the next visit. The final visit, on Week 16, will last 2 hours and
      will consist of the same tests administered at the baseline visit in addition to the
      neuropsychological tests administered at the screening visit. The full range of tests will
      measure physical health, verbal memory, mental flexibility, attention, life impairment, and
      life satisfaction.
    

Intervention name(s): Galantamine-ER; Galantamine placebo
Intervention type(s): Drug; Drug
Intervention description(s): Galantamine-ER 8 to 24 mg per day for 16 weeks; Galantamine placebo 8 to 24 mg per day for 16 weeks
Other intervention name(s): Razadyne-ER; placebo
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment