Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia (STAR-1)

Georgetown University

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: CDP-choline; Drug: Galantamine; Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00509067

R34MH077849 (U.S. NIH Grant/Contract)

DATR A5-ETBD

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Participants assigned to receive galantamine and CDP-choline

Treatment:

Drug: CDP-choline

Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole

Drug: Galantamine

B

Placebo Comparator group

Description:

Participants assigned to receive placebo

Treatment:

Drug: Placebo

Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole