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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00053703 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Schizophrenia and Related Disorders in Children and Adolescents |
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.
Ages Eligible for Study: | 8 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
"*" OLA exclusion not applicable after 11/2005
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. | The University of North Carolina, Chapel Hill |
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 |
ClinicalTrials.gov Identifier: | NCT00053703 History of Changes |
Health Authority: | United States: Federal Government |
Psychotic Disorders Schizophreniform Disorder |
Neurotransmitter Agents Molindone Tranquilizing Agents Olanzapine Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Serotonin Schizophrenia Dopamine Mental Disorders Dopamine Agents Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Molindone Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Risperidone Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Schizophrenia Serotonin Antagonists Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |