CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 116 enrolled
Drug / intervention
Risperidone +2 moredrug
Likely dose
Risperidone 0.5-6 mg daily, or olanzapine 5-20 mg daily, or molindone 10-140 mg dailyAI-extracted
Key inclusion· 5
  • ✓Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms
  • ✓Free of depot antipsychotic medication for at least 6 months
  • ✓Oral antipsychotic medication at entry allowed if no adequate trial during current psychotic episode
  • ✓If on antidepressant or mood stabilizer, must be at stable dose for ≥30 days prior to entry
Key exclusion· 9
  • ✕Prior adequate trial of risperidone (≥8 weeks with ≥2 weeks at 6 mg/day), olanzapine (≥8 weeks with ≥2 weeks at 20 mg/day), or molindone (≥8 weeks with ≥2 weeks at 140 mg/day) during current episode
  • ✕Intolerance or nonresponse to risperidone, olanzapine, or molindone during any previous treatment
  • ✕Bipolar affective disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified
  • ✕Currently meeting DSM-IV criteria for major depression episode

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

Search/NCT00053703
NCT00053703Phase 4Completed
CompareCT.gov

Treatment of Schizophrenia and Related Disorders in Children and Adolescents

University of North Carolina, Chapel Hill·interventional·Posted Feb 5, 2003·Updated Mar 26, 2014

In Brief

A Phase 4 clinical trial evaluating Risperidone, Olanzapine (enrollment closed in this treatment), and 1 other intervention for Schizophrenia. Completed, enrolled 116 participants across 4 sites.

Detailed Summary

This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 5, 2003
Enrollment StartFeb 1, 2002
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 23.4 years ago

Interventions

Risperidonedrug

oral risperidone 0.5mg to 6mg daily for up to 52 weeks

Olanzapine (enrollment closed in this treatment)drug

oral olanzapine 5-20mg per day for up to 52 weeks

Molindonedrug

oral molindone from 10-140mg/daily for up to 52 weeks