Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (TEOSS)

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill Identifier:
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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
We are referring to the population of participants who had baseline assessment, took at least one dose of trial medication, and had at least one post-baseline assessment. There were 3 randomized subjects, on in each treatment group, who did not take at least one dose of study medication and are not included.

Reporting Groups
Olanzapine oral olanzapine 5-20mg per day 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
Total Total of all reporting groups

Baseline Measures
    Olanzapine     Risperidone     Molindone     Total  
Number of Participants  
[units: participants]
  35     41     40     116  
[units: participants]
<=18 years     35     40     39     114  
Between 18 and 65 years     0     1     1     2  
>=65 years     0     0     0     0  
[units: years]
Mean (Standard Deviation)
  13.84  (2.41)     14.54  (2.38)     14.3  (2.4)     14.25  (2.39)  
[units: participants]
Female     10     14     17     41  
Male     25     27     23     75  
Region of Enrollment  
[units: participants]
United States     35     41     40     116  

  Outcome Measures
  Show All Outcome Measures

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

  More Information