Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00053703

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Child Mental Health Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Molindone hydrochloride Risperidone Olanzapine Molindone

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

psychotic symptoms

Enrollment:	119
Study Start Date:	February 2002
Study Completion Date:	May 2007

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.

Eligibility

Ages Eligible for Study:	8 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

"*" OLA exclusion not applicable after 11/2005

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053703

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

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):

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. Epub 2010 May 1.

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. Epub 2008 Sep 15.

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 February 12, 2012