CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Risperdal 4 mg per dayAI-extracted
Key inclusion· 4
  • ✓DSM-IV criteria for schizophrenia or schizoaffective disorder
  • ✓Currently receiving clozapine treatment
  • ✓Moderate illness severity with inadequate positive symptom response to clozapine
  • ✓At least 6 months of clozapine treatment with documented blood level ≥350 ng/ml (clozapine alone) or ≥450 ng/ml (clozapine + norclozapine)
Key exclusion· 6
  • ✕Organic brain disorder
  • ✕Mental retardation
  • ✕Medical condition whose pathology or treatment could alter schizophrenia presentation or significantly increase treatment risk
  • ✕Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00056498
NCT00056498Phase 4Completed
CompareCT.gov

Clozapine Treatment of Schizophrenic Patients

University of Maryland, Baltimore·interventional·Posted Mar 17, 2003·Updated Oct 1, 2019

In Brief

A Phase 4 clinical trial evaluating Placebo and Risperdal for Schizophrenia. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Ortho-McNeil Janssen Scientific Affairs, LLC

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2003
Enrollment StartDec 1, 2001
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 23.3 years ago

Interventions

Placebodrug

Placebo capsule daily for 16 weeks

Risperdaldrug

Risperdal 4 mg per day for 16 weeks