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| Descriptive Information Fields | |||||||||
| Brief Title † | The Use of Galantamine and CDP-Choline to Treat Adults With Schizophrenia | ||||||||
| Official Title † | Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia | ||||||||
| Brief Summary | This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia. |
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| 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 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Negative symptoms measured on Positive and Negative Syndrome Scale [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Clinical Global Impression [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ] Cognitive measures (MATRICS: attention, memory, processing speed) [ Time Frame: Measured at Baseline and Weeks 8 and 16 ] [ Designated as safety issue: No ] Nicotine use [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ] Electrocardiogram [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: Yes ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Drug: Galantamine Drug: CDP-choline Drug: Placebo Drug: Risperidone |
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| MEDLINE PMIDs | 17349863, 16754836 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 50 | ||||||||
| Start Date † | November 2007 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00509067 | ||||||||
| Organization ID | 1 R34 MH077849 | ||||||||
| Secondary IDs †† | DATR A5-ETBD | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | July 30, 2007 | ||||||||
| Last Updated Date | August 27, 2008 | ||||||||
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