Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509067
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2007-07-30
Brief Title:
Use of Galantamine and CDP-choline Citicoline to Treat Adults With Schizophrenia
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-1
Brief 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 Alzheimers 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 1000 mg daily for the next 4 days and 2000 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 andor 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
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 1000 mg daily for the next 4 days and 2000 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A5-ETBD | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH077849 |
| R34MH077849 | NIH | None | None |