Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Condition(s) targeted: Schizophrenia

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

Phase: Phase 4

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Linmarie Sikich, M.D., Study Chair, Affiliation: University of North Carolina, Chapel Hill

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.

Official title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

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

Change From Baseline in PANSS Negative Symptom Subscale at Week 8

Secondary outcome:

Change From Baseline in Weight at Week 8

Change From Baseline in Barnes Akathisia Scale at Week 8

Change From Baseline in Body Mass Index Change, kg/m2, at Week 8

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.

Minimum age: 8 Years. Maximum age: 19 Years. Gender(s): 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 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

Cambridge Health Alliance, Medford, Massachusetts 02155, United States

University of North Carolina, Chapel Hill, North Carolina 27514, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

University of Washington, Seattle, Washington 98195, United States

Starting date: February 2002
Last updated: February 7, 2014