Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00053703
First received: February 4, 2003
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Risperidone
Drug: Olanzapine (enrollment closed in this treatment)
Drug: Molindone

  Participant Flow


  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks   [ Time Frame: 8 weeks ]

2.  Primary:   Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.   [ Time Frame: 8 weeks ]

3.  Primary:   Change From Baseline in PANSS Negative Symptom Subscale at Week 8   [ Time Frame: 8 weeks ]

4.  Secondary:   Change From Baseline in Weight at Week 8   [ Time Frame: 8 weeks ]

5.  Secondary:   Change From Baseline in Barnes Akathisia Scale at Week 8   [ Time Frame: 8 weeks ]

6.  Secondary:   Change From Baseline in Body Mass Index Change, kg/m2, at Week 8   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The most significant weakness of this study was the sample size, which was sufficient only to detect large differences across the three treatments and limited our ability to identify predictors of response or adverse effects.


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