Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 14, 2003

Last Updated Date

March 4, 2008

Start Date ^†

December 2001

Current Primary Outcome Measures ^†

Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at baseline and every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00056498 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Neuropsychological testing [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

Official Title ^†

Clozapine Treatment of Schizophrenic Patients

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Schizophrenia

Intervention ^†

Drug: Placebo
Drug: Risperdal

Study Arms / Comparison Groups

Active Comparator: Participants assigned to risperidone
Placebo Comparator: Participants assigned to placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

December 2007

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00056498

Responsible Party

Robert W. Buchanan, MD, Maryland Psychiatric Research Center/University of Maryland Baltimore

Secondary IDs ^††

DSIR 83-ATAP

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Robert W Buchanan, MD

Maryland Psychiatric Research Center

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.