Trial Outcomes & Findings for Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (NCT NCT00053703)
NCT ID: NCT00053703
Last Updated: 2014-03-26
Results Overview
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.
COMPLETED
PHASE4
116 participants
8 weeks
2014-03-26
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
41
|
40
|
|
Overall Study
COMPLETED
|
17
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Baseline characteristics by cohort
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
114 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
13.84 years
STANDARD_DEVIATION 2.41 • n=93 Participants
|
14.54 years
STANDARD_DEVIATION 2.38 • n=4 Participants
|
14.3 years
STANDARD_DEVIATION 2.4 • n=27 Participants
|
14.25 years
STANDARD_DEVIATION 2.39 • n=483 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=93 Participants
|
41 participants
n=4 Participants
|
40 participants
n=27 Participants
|
116 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.
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.
Outcome measures
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks
|
-26.6 units on a scale
Standard Deviation 17.8
|
-23.7 units on a scale
Standard Deviation 25.5
|
-27.0 units on a scale
Standard Deviation 17.7
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.
The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.
Outcome measures
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.
|
-8.9 units on a scale
Standard Deviation 6.0
|
-8.4 units on a scale
Standard Deviation 8.1
|
-8.8 units on a scale
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: 8 weeksThe PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.
Outcome measures
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Change From Baseline in PANSS Negative Symptom Subscale at Week 8
|
-5.3 units on a scale
Standard Deviation 7.6
|
-5.1 units on a scale
Standard Deviation 7.8
|
-5.8 units on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.
change in weight from baseline to week 8 in kg
Outcome measures
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Change From Baseline in Weight at Week 8
|
6.12 Kg
Standard Deviation 3.60
|
3.64 Kg
Standard Deviation 3.95
|
0.34 Kg
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.
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.
Outcome measures
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Change From Baseline in Barnes Akathisia Scale at Week 8
|
0.19 units on a scale
Standard Deviation 2.12
|
0.41 units on a scale
Standard Deviation 2.37
|
1.23 units on a scale
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.
Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.
Outcome measures
| Measure |
Olanzapine
n=35 Participants
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 Participants
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 Participants
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Change From Baseline in Body Mass Index Change, kg/m2, at Week 8
|
1.27 kg/m2
Standard Deviation 1.51
|
2.20 kg/m2
Standard Deviation 1.24
|
0.15 kg/m2
Standard Deviation 1.26
|
Adverse Events
Olanzapine
Risperidone
Molindone
Serious adverse events
| Measure |
Olanzapine
n=35 participants at risk
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 participants at risk
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 participants at risk
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization
|
5.7%
2/35 • Number of events 2 • 8 weeks, Systematic events
|
9.8%
4/41 • Number of events 4 • 8 weeks, Systematic events
|
2.5%
1/40 • Number of events 1 • 8 weeks, Systematic events
|
|
Psychiatric disorders
Suicidal Thoughts (life-threatening)
|
0.00%
0/35 • 8 weeks, Systematic events
|
4.9%
2/41 • Number of events 2 • 8 weeks, Systematic events
|
2.5%
1/40 • Number of events 1 • 8 weeks, Systematic events
|
Other adverse events
| Measure |
Olanzapine
n=35 participants at risk
oral olanzapine 5-20mg per day for up to 52 weeks
|
Risperidone
n=41 participants at risk
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
|
Molindone
n=40 participants at risk
oral molindone from 10-140mg/daily for up to 52 weeks
|
|---|---|---|---|
|
Psychiatric disorders
Agitation
|
17.1%
6/35 • Number of events 6 • 8 weeks, Systematic events
|
12.2%
5/41 • Number of events 5 • 8 weeks, Systematic events
|
17.5%
7/40 • Number of events 7 • 8 weeks, Systematic events
|
|
Nervous system disorders
Akathisia
|
14.3%
5/35 • Number of events 5 • 8 weeks, Systematic events
|
9.8%
4/41 • Number of events 4 • 8 weeks, Systematic events
|
42.5%
17/40 • Number of events 17 • 8 weeks, Systematic events
|
|
Psychiatric disorders
Anxiety
|
8.6%
3/35 • Number of events 3 • 8 weeks, Systematic events
|
7.3%
3/41 • Number of events 3 • 8 weeks, Systematic events
|
22.5%
9/40 • Number of events 9 • 8 weeks, Systematic events
|
|
Eye disorders
Blurred Vision
|
0.00%
0/35 • 8 weeks, Systematic events
|
9.8%
4/41 • Number of events 4 • 8 weeks, Systematic events
|
10.0%
4/40 • Number of events 4 • 8 weeks, Systematic events
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1 • 8 weeks, Systematic events
|
17.1%
7/41 • Number of events 7 • 8 weeks, Systematic events
|
2.5%
1/40 • Number of events 1 • 8 weeks, Systematic events
|
|
Psychiatric disorders
Depression
|
17.1%
6/35 • Number of events 6 • 8 weeks, Systematic events
|
12.2%
5/41 • Number of events 5 • 8 weeks, Systematic events
|
10.0%
4/40 • Number of events 4 • 8 weeks, Systematic events
|
|
Nervous system disorders
Dystonia
|
17.1%
6/35 • Number of events 6 • 8 weeks, Systematic events
|
12.2%
5/41 • Number of events 5 • 8 weeks, Systematic events
|
2.5%
1/40 • Number of events 1 • 8 weeks, Systematic events
|
|
General disorders
Increase in appetite
|
40.0%
14/35 • Number of events 14 • 8 weeks, Systematic events
|
17.1%
7/41 • Number of events 7 • 8 weeks, Systematic events
|
7.5%
3/40 • Number of events 3 • 8 weeks, Systematic events
|
|
General disorders
Insomnia
|
5.7%
2/35 • Number of events 2 • 8 weeks, Systematic events
|
14.6%
6/41 • Number of events 6 • 8 weeks, Systematic events
|
15.0%
6/40 • Number of events 6 • 8 weeks, Systematic events
|
|
Psychiatric disorders
Irritability
|
25.7%
9/35 • Number of events 9 • 8 weeks, Systematic events
|
19.5%
8/41 • Number of events 8 • 8 weeks, Systematic events
|
22.5%
9/40 • Number of events 9 • 8 weeks, Systematic events
|
|
General disorders
Menstrual Irregularities
|
2.9%
1/35 • Number of events 1 • 8 weeks, Systematic events
|
4.9%
2/41 • Number of events 2 • 8 weeks, Systematic events
|
5.0%
2/40 • Number of events 2 • 8 weeks, Systematic events
|
|
General disorders
Sedation/Drowsiness
|
31.4%
11/35 • Number of events 11 • 8 weeks, Systematic events
|
31.7%
13/41 • Number of events 13 • 8 weeks, Systematic events
|
40.0%
16/40 • Number of events 16 • 8 weeks, Systematic events
|
|
General disorders
weight gain
|
48.6%
17/35 • Number of events 17 • 8 weeks, Systematic events
|
17.1%
7/41 • Number of events 7 • 8 weeks, Systematic events
|
7.5%
3/40 • Number of events 3 • 8 weeks, Systematic events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place