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

Phase 2

Completed

Conditions: Schizophrenia

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

Registration Number: NCT00509067

Lead Sponsor: Georgetown University

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole	Participants assigned to receive galantamine and CDP-choline
B	Placebo	Participants assigned to receive placebo
B	risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole	Participants assigned to receive placebo
A	Galantamine	Participants assigned to receive galantamine and CDP-choline
A	CDP-choline	Participants assigned to receive galantamine and CDP-choline

Primary Outcome Measures

Name	Time	Method
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression	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	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.