Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
NCT ID: NCT00053703
Last Updated: 2014-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
116 participants
INTERVENTIONAL
2002-02-28
2007-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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olanzapine
oral olanzapine 5-20mg per day for up to 52 weeks
Olanzapine (enrollment closed in this treatment)
oral olanzapine 5-20mg per day for up to 52 weeks
risperidone
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Risperidone
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
molindone
oral molindone from 10-140mg/daily for up to 52 weeks
Molindone
oral molindone from 10-140mg/daily for up to 52 weeks
Interventions
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Risperidone
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Olanzapine (enrollment closed in this treatment)
oral olanzapine 5-20mg per day for up to 52 weeks
Molindone
oral molindone from 10-140mg/daily for up to 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 Diagnostic and Statistical Manual version IV (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
8 Years
19 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Linmarie Sikich, MD
Associate Professor
Principal Investigators
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Linmarie Sikich, M.D.
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Locations
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Cambridge Health Alliance
Medford, Massachusetts, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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McCLELLAN J, Sikich L, Findling RL, Frazier JA, Vitiello B, Hlastala SA, Williams E, Ambler D, Hunt-Harrison T, Maloney AE, Ritz L, Anderson R, Hamer RM, Lieberman JA. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): rationale, design, and methods. J Am Acad Child Adolesc Psychiatry. 2007 Aug;46(8):969-978. doi: 10.1097/CHI.0b013e3180691779.
Frazier JA, McCLELLAN J, Findling RL, Vitiello B, Anderson R, Zablotsky B, Williams E, McNAMARA NK, Jackson JA, Ritz L, Hlastala SA, Pierson L, Varley JA, Puglia M, Maloney AE, Ambler D, Hunt-Harrison T, Hamer RM, Noyes N, Lieberman JA, Sikich L. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): demographic and clinical characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Aug;46(8):979-988. doi: 10.1097/chi.0b013e31807083fd.
Findling RL, Johnson JL, McClellan J, Frazier JA, Vitiello B, Hamer RM, Lieberman JA, Ritz L, McNamara NK, Lingler J, Hlastala S, Pierson L, Puglia M, Maloney AE, Kaufman EM, Noyes N, Sikich L. Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):583-94; quiz 632. doi: 10.1016/j.jaac.2010.03.013. Epub 2010 May 1.
Taylor JH, Appel S, Eli M, Alexander-Bloch A, Maayan L, Gur RE, Bloch MH. Time to Clinical Response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study. J Child Adolesc Psychopharmacol. 2021 Feb;31(1):46-52. doi: 10.1089/cap.2020.0030. Epub 2020 Jul 1.
Taylor JH, Jakubovski E, Gabriel D, Bloch MH. Predictors and Moderators of Antipsychotic-Related Weight Gain in the Treatment of Early-Onset Schizophrenia Spectrum Disorders Study. J Child Adolesc Psychopharmacol. 2018 Sep;28(7):474-484. doi: 10.1089/cap.2017.0147. Epub 2018 Jun 19.
Gabriel D, Jakubovski E, Taylor JH, Artukoglu BB, Bloch MH. Predictors of treatment response and drop out in the Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) study. Psychiatry Res. 2017 Sep;255:248-255. doi: 10.1016/j.psychres.2017.05.038. Epub 2017 May 30.
Frazier JA, Giuliano AJ, Johnson JL, Yakutis L, Youngstrom EA, Breiger D, Sikich L, Findling RL, McClellan J, Hamer RM, Vitiello B, Lieberman JA, Hooper SR. Neurocognitive outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders study. J Am Acad Child Adolesc Psychiatry. 2012 May;51(5):496-505. doi: 10.1016/j.jaac.2012.02.001. Epub 2012 Mar 13.
Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, Puglia M, Maloney AE, Michael E, De Jong S, Slifka K, Noyes N, Hlastala S, Pierson L, McNamara NK, Delporto-Bedoya D, Anderson R, Hamer RM, Lieberman JA. Double-blind comparison of first- and second-generation antipsychotics in early-onset schizophrenia and schizo-affective disorder: findings from the treatment of early-onset schizophrenia spectrum disorders (TEOSS) study. Am J Psychiatry. 2008 Nov;165(11):1420-31. doi: 10.1176/appi.ajp.2008.08050756. Epub 2008 Sep 15.
Other Identifiers
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U01 MH 615218-01A
Identifier Type: -
Identifier Source: org_study_id
NCT00030251
Identifier Type: -
Identifier Source: nct_alias
NCT00043290
Identifier Type: -
Identifier Source: nct_alias
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