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| 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. |
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| 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. |
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| 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 |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 119 | ||||
| Start Date † | February 2002 | ||||
| Completion Date | May 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
"*" OLA exclusion not applicable after 11/2005 |
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| Gender | Both | ||||
| Ages | 8 Years to 19 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| 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 † |
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| 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 | ||||