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TEOSS: Treatment of Schizophrenia in Children and Adolescents
NCT00053703Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2002
- Primary completion
- May 2007
- Countries
- 1
- Sponsor
- University of North Carolina at Chapel Hill
- Modality
- Small Molecules
- Conditions
- schizophreniaschizoaffective disorderschizophreniform disorder
01
Overview
Phase 4, randomised trial in schizophrenia, schizoaffective disorder and schizophreniform disorder comparing Olanzapine Arm, Risperidone Arm and Molindone Arm (3 arms). Primary endpoints: Positive and Negative Syndrome Scale Total at 8 weeks, Positive and Negative Syndrome Scale Positive Symptom Subscale at 8 weeks and 1 more. Started Feb 2002; status: completed.
02
Design
3 arms- Study design
- Randomized
Olanzapine Arm
Oral olanzapine 5-20mg per day for up to 52 weeks
Risperidone Arm
Oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Molindone Arm
Oral molindone from 10-140mg/daily for up to 52 weeks
03
Who it enrols
Children and adolescents with schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms. Must be free of depot antipsychotics for 6 months. Excludes patients with bipolar disorder, PTSD, personality disorder, major depression, substance abuse, mental retardation, or uncontrolled suicide/homicide risk.
04
Endpoints
Primary
Positive and Negative Syndrome Scale Total
Positive and Negative Syndrome Scale Positive Symptom Subscale
Positive and Negative Syndrome Scale Negative Symptom Subscale
Secondary
Weight
Barnes Akathisia Scale
Body Mass Index
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