A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if adding extended-release galantamine
      hydrobromide, compared with adding placebo, to current atypical antipsychotic therapy is well
      tolerated and effective in improving cognitive impairment in patients with schizophrenia.
    

Detailed description: 
      Galantamine acts on acetylcholinesterase, and has been shown to effectively treat cognitive
      symptoms in patients with Alzheimer's disease. Previous cellular research of nicotinic
      receptors has shown promising results, and it is theorized that the nicotinic system of
      patients with schizophrenia may be abnormal and may play an important role in the cognitive
      symptoms associated with schizophrenia. It is also postulated that galantamine may improve
      neuropsychiatric symptoms such as hallucinations, delusions, and apathy in patients with
      Alzheimer's disease. Atypical antipsychotic medications are effective treatment for
      schizophrenia patients but some symptoms remain. Therefore, galantamine may be a useful
      cotreatment for schizophrenia patients on atypical antipsychotic treatment. This is a pilot
      dose-ranging, randomized (patients are assigned different treatments based on chance),
      double-blind (neither the patient nor the physician knows whether drug or placebo is being
      taken, or at what dosage), placebo-controlled multicenter study that examines the effects of
      taking extended-release galantamine hydrobromide (16 or 24 mg once daily) or placebo on the
      effectiveness in reducing symptoms of schizophrenia patients who are already taking an
      atypical antipsychotic medication. The safety of combined treatment is also examined.
      Measures of effectiveness include the Positive and Negative Syndrome Scale (PANSS) to measure
      neuropsychiatric symptoms of schizophrenia; the Clinical Global Impression (CGI) scale to
      measure change over the course of the study; the Brief Assessment of Cognition in
      Schizophrenia (BACS) for verbal memory and learning, working memory, motor function,
      attention, verbal fluency, and executive functioning; the Continuous Performance Test (CPT)
      for sustained attention and distractability; reaction time test (RTT) and finger tapping test
      (FTT) for psychomotor speed; Lexical and Semantic Fluency Test (LSFT) for language skills. As
      schizophrenia patients are a population with high nicotine use, and galantamine may act on
      nicotine receptors, blood levels of nicotine are also measured as varying nicotine levels
      could alter the effects of galantamine. The null hypothesis that there is no difference
      between the 2 groups (galantamine cotreatment and placebo) will be tested for each of the
      efficacy measurements (total PANSS, BACS, and CGI scores) at Week 8. Measures of safety
      include physical examinations, electrocardiograms (ECGs), clinical laboratory tests,
      measurement of plasma prolactin concentrations, pregnancy test for women, and incidence of
      adverse events. Adverse events that might be related to the medications are also monitored
      using the Simpson-Angus Extrapyramidal Side Effects Scale (SAS), the Barnes Akathisia Rating
      Scale (BARS), and the Abnormal Involuntary Movement Scale (AIMS). Extended-release
      galantamine hydrobromide or matching placebo capsules for once-daily dosing. Patients take 8
      milligrams (mg) per day during Week 1, 16 mg per day during Week 2, and 16 mg or 24 mg per
      day (depending on randomization) during Weeks 3 to 8. Treatment groups are placebo capsule,
      16 mg capsule, 24 mg capsule.
    

Intervention name(s): Extended-release galantamine hydrobromide
Intervention type(s): Drug
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; cognitive impairment; galantamine; acetylcholinesterase inhibitors; antipsychotic drugs; BACS