Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Molindone; Drug: Risperidone; Drug: Olanzapine (enrollment closed in this treatment)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00053703

U01MH061464-01A1 (U.S. NIH Grant/Contract)

U01MH062726-01 (U.S. NIH Grant/Contract)

U01MH062726 (U.S. NIH Grant/Contract)

U01 MH 615218-01A

U01MH061355-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 8 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 3 patient groups

olanzapine

Active Comparator group

Description:

oral olanzapine 5-20mg per day for up to 52 weeks

Treatment:

Drug: Olanzapine (enrollment closed in this treatment)

risperidone

Active Comparator group

Description:

oral risperidone 0.5mg to 6mg daily for up to 52 weeks

Treatment:

Drug: Risperidone

molindone

Active Comparator group

Description:

oral molindone from 10-140mg/daily for up to 52 weeks

Treatment:

Drug: Molindone