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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)

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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  90
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 No
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.




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