Full Text View
Tabular View
No Study Results Posted
Related Studies
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
This study has been completed.
Study NCT00053703   Information provided by National Institute of Mental Health (NIMH)
First Received: February 4, 2003   Last Updated: December 18, 2007   History of Changes

February 4, 2003
December 18, 2007
February 2002
 
psychotic symptoms
Same as current
Complete list of historical versions of study NCT00053703 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Treatment of Schizophrenia and Related Disorders in Children and Adolescents

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Schizophrenia
  • Drug: Risperidone
  • Drug: Olanzapine (enrollment closed in this treatment)
  • Drug: Molindone
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
119
May 2007
 

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

Both
8 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053703
 
U01 MH62726, DDTR B2-NDS, R01 MH61528, R01 MH61355, R01 MH62726, R01 MH61464
National Institute of Mental Health (NIMH)
 
Study Chair: Linmarie Sikich, M.D. The University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP