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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From February 2002 to May 2006, youth were screened at four academic sites: University of North Carolina at Chapel Hill, McLean Hospital and Cambridge Health Alliance at Harvard Medical School, University of Washington, and Case Western Reserve University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    Olanzapine     Risperidone     Molindone  
STARTED     35     41     40  
COMPLETED     17     28     25  
NOT COMPLETED     18     13     15  



  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
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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
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Time Frame 8 weeks, Systematic events
Additional Description No text entered.

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

Serious Adverse Events
    Olanzapine     Risperidone     Molindone  
Total, serious adverse events        
# participants affected / at risk     2/35 (5.71%)     4/41 (9.76%)     2/40 (5.00%)  
Psychiatric disorders        
Psychiatric Hospitalization      
# participants affected / at risk     2/35 (5.71%)     4/41 (9.76%)     1/40 (2.50%)  
# events     2     4     1  
Suicidal Thoughts (life-threatening) *      
# participants affected / at risk     0/35 (0.00%)     2/41 (4.88%)     1/40 (2.50%)  
# events     0     2     1  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment




  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