Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

Key facts

Study ID

NCT00056498

Run by

University of Maryland, Baltimore

People needed

65

Starts

2001-12-01

Expected to finish

2007-12-01

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV criteria for schizophrenia or schizoaffective disorder
• Current clozapine treatment
• Moderate illness severity and inadequate positive symptom response to clozapine treatment
• 6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

You may not qualify if…

• Organic brain disorder
• Mental retardation
• Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
• Pregnancy
• DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month
• Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks

Where it is running

• Maryland Psychiatric Research Center — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

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