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

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

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

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 ]

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.