Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of galantamine and CDP-choline in improving
      symptoms associated with schizophrenia.
    

Detailed description: 
      Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans
      each year. Schizophrenia can be extremely disabling, causing people to hear voices,
      experience paranoia or hallucinations, believe that others are controlling their thoughts,
      and even fail at maintaining a job or caring for themselves. Current medications help to
      relieve most of these negative symptoms, but not all. Many people with schizophrenia still
      suffer from low energy levels, an inability to concentrate, and memory loss. Galantamine is a
      medication that is used to improve memory and energy levels in people with Alzheimer's
      disease, and CDP-choline is a nutritional supplement. The purpose of this study is to
      evaluate the effectiveness of adding galantamine and CDP-choline to a stable anti-psychotic
      medication regimen of risperidone as a way of improving symptoms in adults with
      schizophrenia.

      Participants in this double-blind study will attend an initial screening during which they
      will undergo a physical exam, an electrocardiogram, and blood and urine collection.
      Participants will then be randomly assigned to receive galantamine and CDP-choline or a
      placebo treatment for 16 weeks. Participants assigned to the treatment group will take 500 mg
      of CDP-choline daily for the first 3 days, 1,000 mg daily for the next 4 days, and 2,000 mg
      daily for the following 15 weeks. Participants assigned to the treatment group will also take
      8 mg of galantamine daily for the first week, 16 mg daily for the next week, and 24 mg daily
      for the following 14 weeks. Participants assigned to the control group will take two types of
      placebo pills every day for 16 weeks. All participants will continue to take their regular
      regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout
      the trial in addition to their assigned treatment. Staff members will meet with participants
      during the first week of the study and every 4 weeks afterward until study completion. During
      these meetings, participants will identify any side effects, report nicotine intake, breathe
      into a machine that measures the amount of nicotine in the body, and complete written and
      computerized tasks on concentration and memory. Each meeting may last up to 3 hours. On the
      last week of the study, blood and urine samples will be collected and an electrocardiogram
      will be administered. Results from this study will be used to evaluate whether CDP-choline
      and galantamine improve schizophrenia symptoms.

      CDP-choline and matching placebos were purchased from LifeLink Corporation. Galantamine and
      matching placebos were prepared and donated by Ortho McNeil Janssen Scientific Affairs LLC.
    

Intervention name(s): Galantamine; CDP-choline; Placebo; risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.; CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.; The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.; All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.
Other intervention name(s): Razadyne
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone; Choline; Galantamine; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizoaffective Disorder; Acetylcholine; Nicotinic Receptors; Nicotine; Galantamine; negative symptoms