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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
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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
  Description
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  
Age  
[units: participants]
       
<=18 years     35     40     39     114  
Between 18 and 65 years     0     1     1     2  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  13.84  ± 2.41     14.54  ± 2.38     14.3  ± 2.4     14.25  ± 2.39  
Gender  
[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 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Change From Baseline in Barnes Akathisia Scale at Week 8
Measure Description Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.
Time Frame 8 weeks  
Safety Issue Yes  

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.
All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Reporting Groups
  Description
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

Measured Values
    Olanzapine     Risperidone     Molindone  
Number of Participants Analyzed  
[units: participants]
  35     41     40  
Change From Baseline in Barnes Akathisia Scale at Week 8  
[units: units on a scale]
Mean ± Standard Deviation
  0.19  ± 2.12     0.41  ± 2.37     1.23  ± 3.34  

No statistical analysis provided for Change From Baseline in Barnes Akathisia Scale at Week 8



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.


  More Information