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Home > "T" Clinical Trials Conditions > Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)  Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
For Condition: Schizophreniform Disorder,Schizophrenia,Psychotic Disorders
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to compare the safety, effectiveness, and tolerability of three common antipsychotic medications for the treatment of children and adolescents with schizophrenia, schizophreniform disorder or schizoaffective disorder.
Details: 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. 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 8 Years/19 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 168
Location and Contact Information:
Overall Study Official:
LinmarieSikich, Study Chair, University of North Carolina
University of Washington *Recruiting*
Seattle, Washington, 98195
United States
Recruiting Leslie John 206-713-3717
McLean Hospital *Recruiting*
Belmont, Massachusetts, 02478
United States
Recruiting Emily Gerstein 617-855-3694
University of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Johna Hughes 919-966-2162
University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Denise Bedoya 216-844-4964
Additional Information:
Study ID Numbers: 62726-01; 1R01MH61528-01A1,1R01MH62726-01,1R01MH61464-01A1,1R01MH61355-01A1
Study Start Date: February 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053703
Other Psychotic Disorders Studies:
1. Inpatient Evaluation of Adults with Schizophrenia
2. TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices")
3. Safety and efficacy of an anti-psychotic in subjects with schizophrenia
4. The Assessment of a weight-gain agent for the Treatment of Olanzapine-Associated Anti-obesity Agent in Patients with Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
5. Medication Adherence in Older People with Psychosis
Related Studies:
Other Psychotic Disorders Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
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