Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Buchanan, Robert W., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00056498
First received: March 14, 2003
Last updated: June 12, 2012
Last verified: June 2012

March 14, 2003
June 12, 2012
December 2001
December 2007   (final data collection date for 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 ]
Scale assesses psychotic symptoms on a 20-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe.
Not Provided
Complete list of historical versions of study NCT00056498 on ClinicalTrials.gov Archive Site
Neuropsychological Testing [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
Clozapine Treatment of Schizophrenic Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Placebo
    Placebo capsule daily for 16 weeks
  • Drug: Risperdal
    Risperdal 4 mg per day for 16 weeks
    Other Name: Risperidone
  • Active Comparator: Active
    Participants assigned to risperidone
    Intervention: Drug: Risperdal
  • Placebo Comparator: Placebo
    Participants assigned to placebo
    Intervention: Drug: Placebo
Weiner E, Conley RR, Ball MP, Feldman S, Gold JM, Kelly DL, Wonodi I, McMahon RP, Buchanan RW. Adjunctive risperidone for partially responsive people with schizophrenia treated with clozapine. Neuropsychopharmacology. 2010 Oct;35(11):2274-83. Epub 2010 Jul 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00056498
R01 MH045074, DSIR 83-ATAP
Yes
Buchanan, Robert W., National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Robert W Buchanan, MD University of Maryland
National Institute of Mental Health (NIMH)
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP