Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Risperidone Drug: Olanzapine (enrollment closed in this treatment) Drug: Molindone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treatment of Schizophrenia and Related Disorders in Children and Adolescents |
- psychotic symptoms
| Enrollment: | 119 |
| Study Start Date: | February 2002 |
| Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 8 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Cambridge Health Alliance | |
| Medford, Massachusetts, United States, 02155 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Study Chair: | Linmarie Sikich, M.D. | University of North Carolina, Chapel Hill |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00053703 History of Changes |
| Obsolete Identifiers: | NCT00030251, NCT00043290 |
| Other Study ID Numbers: | U01 MH62726, DDTR B2-NDS, R01 MH61528, R01 MH61355, R01 MH62726, R01 MH61464 |
| Study First Received: | February 4, 2003 |
| Last Updated: | December 18, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Psychotic Disorders Schizophreniform Disorder |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Molindone Risperidone Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013