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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00509067 |
This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Galantamine Drug: CDP-choline Drug: Placebo Drug: Risperidone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants assigned to receive galantamine and CDP-choline
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Drug: Galantamine
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.
Drug: CDP-choline
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.
Drug: Risperidone
All participants will continue to take their regular regimen of risperidone throughout the trial in addition to their assigned treatment.
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B: Placebo Comparator
Participants assigned to receive placebo
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Drug: Placebo
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.
Drug: Risperidone
All participants will continue to take their regular regimen of risperidone throughout the trial in addition to their assigned treatment.
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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 17 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 16 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 15 weeks. Participants assigned to the control group will take two placebo pills every day for 17 weeks. All participants will continue to take their regular regimen of risperidone 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephanie M Rosse, BS | 202-745-8000 ext 6172 | Stephanie.Rosse@va.gov |
Contact: Barbara L. Schwartz, PhD | 202-745-8000 ext 7206 | Barbara.Schwartz@va.gov |
United States, District of Columbia | |
Washington Veterans Affairs Medical Center | Recruiting |
Washington, District of Columbia, United States, 20422 | |
Contact: Stephanie M. Rosse, BS 202-745-8000 ext 6172 Stephanie.Rosse@va.gov | |
Contact: Barbara L. Schwartz, PhD 202-745-8000 ext 7206 Barbara.Schwartz@va.gov | |
Principal Investigator: Stephen I. Deutsch, PhD, MD | |
Sub-Investigator: Richard B. Rosse, MD | |
Sub-Investigator: Nina Schooler, PhD | |
Sub-Investigator: Barbara L. Schwartz, PhD |
Principal Investigator: | Stephen I. Deutsch, PhD, MD | Washington Veterans Affairs Medical Center |
Responsible Party: | Georgetown University/ VA Medical Center, Washington DC ( Stephen I. Deutsch, MD, PhD/ ACOS for Mental Health Service ) |
Study ID Numbers: | 1 R34 MH077849, DATR A5-ETBD |
Study First Received: | July 30, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00509067 |
Health Authority: | United States: Food and Drug Administration |
schizoaffective disorder acetylcholine nicotinic receptors |
nicotine galantamine negative symptoms |
Nicotine polacrilex Choline Galantamine Risperidone Serotonin Schizophrenia Dopamine |
Mental Disorders Nicotine Cytidine Diphosphate Choline Psychotic Disorders Acetylcholine Schizophrenia and Disorders with Psychotic Features |
Antimetabolites Parasympathomimetics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Cholinergic Agents Serotonin Antagonists Therapeutic Uses Nootropic Agents Lipotropic Agents Tranquilizing Agents Antilipemic Agents |
Gastrointestinal Agents Central Nervous System Depressants Enzyme Inhibitors Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Cholinesterase Inhibitors Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |