Conditions: Schizophrenia
Keywords: Psychotic Disorders Schizophreniform Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

Brief 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.

Detailed description:
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. After 11/2005, no additional patients will be assigned to olanzapine treatment. 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.

Arms:
arm 1: oral olanzapine 5-20mg per day for up to 52 weeks arm 2: oral risperidone 0.5mg to 6mg daily for up to 52 weeks arm 3: oral molindone from 10-140mg/daily for up to 52 weeks

Interventions: intervention 1: Risperidone intervention 2: Olanzapine (enrollment closed in this treatment) intervention 3: Molindone
Intervention descriptions: intervention 1: oral risperidone 0.5mg to 6mg daily for up to 52 weeks intervention 2: oral olanzapine 5-20mg per day for up to 52 weeks intervention 3: oral molindone from 10-140mg/daily for up to 52 weeks

Protocol document: