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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

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

History of Changes

Results First Received: September 16, 2013

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

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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
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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
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

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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 ]

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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 [Units: Participants]	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:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Primary:

Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. [ Time Frame: 8 weeks ]

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3. Primary:

Change From Baseline in PANSS Negative Symptom Subscale at Week 8 [ Time Frame: 8 weeks ]

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4. Secondary:

Change From Baseline in Weight at Week 8 [ Time Frame: 8 weeks ]

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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 [Units: Participants]	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 ]

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6. Secondary:

Change From Baseline in Body Mass Index Change, kg/m2, at Week 8 [ Time Frame: 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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.

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