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Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

NCT00053703 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2014-03-26

Study results available
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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.

Conditions

Interventions

DRUG

Risperidone

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

DRUG

Olanzapine (enrollment closed in this treatment)

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

DRUG

Molindone

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Linmarie Sikich, M.D. · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00053703 on ClinicalTrials.gov