The purpose of this study is to compare the safety, effectiveness, and tolerability of three common antipsychotic medications for the treatment of children and adolescents with schizophrenia, schizophreniform disorder or schizoaffective disorder.

Condition	Treatment or Intervention	Phase
Schizophrenia Psychotic Disorders Schizophreniform Disorder	Drug: Risperidone  Drug: Olanzapine  Drug: Molindone	Phase IV

Further Study Details: 

Primary Outcomes: psychotic symptoms
Expected Total Enrollment:  168

Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active psychotic symptoms.

Participants are randomly assigned to receive risperidone (Risperdal), olanzapine (Zyprexa), or molindone (Moban) for 8 weeks. Patients with significant improvement and without side effects continue maintenance therapy for another 44 weeks. Participants who show significant negative symptoms after 8 weeks may be started on a mood stabilizer or antidepressant. Weight gain, metabolic changes, neurocognition, functional outcome, psychotic symptoms, extrapyramidal side effects, and the ability to sustain effective therapy over time are assessed.

Ages Eligible for Study:  8 Years   -   19 Years,  Genders Eligible for Study:  Both

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 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

Massachusetts
      Harvard Medical School- Cambridge Hospital, Cambridge,  Massachusetts,  02143,  United States; Recruiting
North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States; Recruiting
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Washington
      University of Washington, Seattle,  Washington,  98195,  United States; Recruiting

Study chairs or principal investigators

Linmarie Sikich, M.D.,  Study Chair,  University of North Carolina   

Study ID Numbers:  62726-01; 1R01MH61528-01A1; 1R01MH61355-01A1; 1R01MH62726-01; 1R01MH61464-01A1
Record last reviewed:  November 2004
Last Updated:  November 15, 2004
Record first received:  February 4, 2003
ClinicalTrials.gov Identifier:  NCT00053703
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08