Phase 4
N=65
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00056498 ↗Enrolled (actual)
65
Serious AEs
4.6%
Results posted
Jul 2012
Primary outcome: Primary: Positive Symptom Item Scores by Week and Treatment Group — 15.5; 15.5; 14.6; 15.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Risperdal (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Symptom Item Scores by Week and Treatment Group |
15.5; 15.5; 14.6; 15.1; 13.3; 14.4 | — |
| SECONDARY Neuropsychological Testing - Overall Composite Z-score |
0.02; -0.03; 0.12; 0.07 | — |
| SECONDARY Negative Symptom Total Score by Week and Treatment Group |
32.3; 33.0; 30.8; 34.0; 29.8; 32.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00056498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.