Overview

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Molindone
Olanzapine
Risperidone
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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