ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00053703
Recruitment Status : Completed
First Posted : February 5, 2003
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Risperidone
Drug: Olanzapine (enrollment closed in this treatment)
Drug: Molindone

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

Measure Type Primary
Measure Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks
Measure Description Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores > that 60 are considered clinically significant.
Time Frame 8 weeks  

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 
Participants Analyzed   35   41   40 
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -26.6  (17.8)   -23.7  (25.5)   -27.0  (17.7) 


Statistical Analysis 1 for Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

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

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

Measure Type Secondary
Measure Title Change From Baseline in Weight at Week 8
Measure Description change in weight from baseline to week 8 in kg
Time Frame 8 weeks  

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 
Participants Analyzed   35   41   40 
Change From Baseline in Weight at Week 8 
[Units: Kg]
Mean (Standard Deviation) 		 6.12  (3.60)   3.64  (3.95)   0.34  (2.86) 

No statistical analysis provided for Change From Baseline in Weight at Week 8



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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