Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Completed · Phase 4

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00053703

Run by

University of North Carolina, Chapel Hill

People needed

116

Starts

2002-02-01

Expected to finish

2007-05-01

Last updated by the study team

2014-03-26

Who can join

Age: 8 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms
• Free of depot antipsychotic medication for at least 6 months. Oral antipsychotic medication at entry into the study is allowed, provided the participant has not had an adequate trial during the present episode of psychosis.
• If taking antidepressant or mood stabilizing medication, stable dosing for at least 30 days prior to entry.
• Good physical health

You may not qualify if…

• Risperidone (RIS), olanzapine (OLA)*, or molindone (MOL) for 8 weeks or more during THIS episode, with 2 weeks at the maximal dose (6 mg/day of RIS, 20 mg/day of OLA, or 140 mg/day of MOL)
• If using antidepressant and/or mood stabilizing medications, treatment for fewer than 30 days immediately before entry
• Intolerance or nonresponse to RIS, OLA*, or MOL during any previous treatment
• Bipolar affective disorder,post traumatic stress disorder, personality disorder, or psychosis not otherwise specified
• Currently meeting Diagnostic and Statistical Manual version IV (DSM IV) criteria for major depression episode
• DSM IV criteria for substance abuse or dependence with intention to continue illicit substance abuse
• Endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics
• Mental retardation
• Risk of suicide or homicide that is not adequately controlled in the current setting
• Pregnancy or refusal to practice contraception during the study
• "*" OLA exclusion not applicable after 11/2005

Where it is running

• Cambridge Health Alliance — Medford, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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