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

Summary

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

Conditions

• Schizophrenia

Interventions

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.

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

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• Georgetown University

  lead OTHER

Principal Investigators

• Stephen I. Deutsch, PhD, MD · Washington Veterans Affairs Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States

Study Locations