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

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Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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

Descriptive Information Fields

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Schizophrenia

Intervention ^†

Drug: Placebo
Drug: Risperdal

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

December 2001

Completion Date

December 2007

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

Administrative Information Fields

NCT ID ^†

NCT00056498

Organization ID

R01 MH45074

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

First Received Date ^†

March 14, 2003

Last Updated Date

March 4, 2008

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