Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia (STAR-1)
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| ClinicalTrials.gov Identifier: NCT00509067 |
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Recruitment Status :
Completed
First Posted : July 31, 2007
Results First Posted : February 7, 2014
Last Update Posted : April 11, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Galantamine Drug: CDP-choline Drug: Placebo Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia |
| Study Start Date : | November 2007 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
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.
Other Name: Razadyne 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, olanzapine, quetiapine, ziprasidone, and/or aripiprazole 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. |
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Placebo Comparator: B
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, olanzapine, quetiapine, ziprasidone, and/or aripiprazole 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. |
- Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ]The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.
- Clinical Global Impression [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ]The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill).
- MATRICS Verbal Learning and Memory [ Time Frame: Measured at Baseline and Weeks 8 and 16 ]The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Eligible for care within the Veterans Affairs Medical system
- Taking risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole (oral or injection)
Exclusion Criteria:
- Significant liver, kidney, lung, endocrine, active peptic ulcer, or cardiovascular disease
- Seizure disorder and/or head injury
- Substance use or abuse within 3 months of study entry
- Pregnant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509067
| United States, District of Columbia | |
| Washington Veterans Affairs Medical Center | |
| Washington, District of Columbia, United States, 20422 | |
| Principal Investigator: | Stephen I. Deutsch, PhD, MD | Washington Veterans Affairs Medical Center |
Publications:
| Responsible Party: | Stephen I. Deutsch, Professor and Chair, Dept. of Psychiatry & Behavioral Sciences, Eastern Virginia Medical School, National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00509067 |
| Other Study ID Numbers: |
R34MH077849 ( U.S. NIH Grant/Contract ) R34MH077849 ( U.S. NIH Grant/Contract ) DATR A5-ETBD |
| First Posted: | July 31, 2007 Key Record Dates |
| Results First Posted: | February 7, 2014 |
| Last Update Posted: | April 11, 2018 |
| Last Verified: | February 2018 |
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Schizoaffective Disorder Acetylcholine Nicotinic Receptors |
Nicotine Galantamine negative symptoms |
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Risperidone Quetiapine Fumarate Aripiprazole Ziprasidone Choline Galantamine Cytidine Diphosphate Choline Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Antidepressive Agents |