Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

University of North Carolina, Chapel Hill116 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Schizophrenia

Interventions

RisperidoneDRUG

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

Olanzapine (enrollment closed in this treatment)DRUG

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

MolindoneDRUG

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks

Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores \> that 60 are considered clinically significant.

Time frame: 8 weeks

Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.

The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.

Time frame: 8 weeks

Change From Baseline in PANSS Negative Symptom Subscale at Week 8

The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.

Time frame: 8 weeks

Secondary Outcomes

Change From Baseline in Weight at Week 8

change in weight from baseline to week 8 in kg

Time frame: 8 weeks

Data from ClinicalTrials.gov

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