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Phase 4 N=116 Randomized Quadruple-blind Treatment

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00053703 ↗
Enrolled (actual)
116
Serious AEs
6.9%
Results posted
Mar 2014
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks — -26.6; -23.7; -27.0 units on a scale — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Risperidone (Drug); Olanzapine (enrollment closed in this treatment) (Drug); Molindone (Drug)
Age
Pediatric, Adult · 8+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
May 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks		 -26.6; -23.7; -27.0 0.05
PRIMARY
Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.		 -8.9; -8.4; -8.8 —
PRIMARY
Change From Baseline in PANSS Negative Symptom Subscale at Week 8		 -5.3; -5.1; -5.8 —
SECONDARY
Change From Baseline in Weight at Week 8		 6.12; 3.64; 0.34 —
SECONDARY
Change From Baseline in Barnes Akathisia Scale at Week 8		 0.19; 0.41; 1.23 —
SECONDARY
Change From Baseline in Body Mass Index Change, kg/m2, at Week 8		 1.27; 2.20; 0.15 —

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00053703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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