Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) - Tabular View

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Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

This study has been completed.

Study NCT00053703. Last updated on December 18, 2007. Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Official Title ^†

Treatment of Schizophrenia and Related Disorders in Children and Adolescents

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

psychotic symptoms

Secondary Outcome Measure ^†

Condition ^†

Schizophrenia

Intervention ^†

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

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

119

Start Date ^†

February 2002

Completion Date

May 2007

Eligibility 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

"*" OLA exclusion not applicable after 11/2005

Gender

Both

Ages

8 Years to 19 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00053703

Organization ID

U01 MH62726

Secondary IDs ^††

DDTR B2-NDS, R01 MH61528, R01 MH61355, R01 MH62726, R01 MH61464

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Study Chair:

Linmarie Sikich, M.D.

The University of North Carolina, Chapel Hill

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

December 2007

First Received Date ^†

February 4, 2003

Last Updated Date

December 18, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.