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Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Placebo (Drug); Risperdal (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Robert W Buchanan, MD, Principal Investigator, Affiliation: University of Maryland


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.

Clinical Details

Official title: Clozapine Treatment of Schizophrenic Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Brief Psychiatric Rating Scale (BPRS)

Secondary outcome: Neuropsychological Testing

Detailed description: Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy. Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- DSM-IV criteria for schizophrenia or schizoaffective disorder

- Current clozapine treatment

- Moderate illness severity and inadequate positive symptom response to clozapine


- 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 Exclusion Criteria:

- 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

Locations and Contacts

Maryland Psychiatric Research Center, Baltimore, Maryland 21228, United States
Additional Information

Starting date: December 2001
Last updated: April 10, 2015

Page last updated: August 23, 2015

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