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Table 3 Data from trials on quetiapine or aripiprazole in patients below 19 years with psychosis used for final power calculation

From: Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

Study (reference) Design and population Intervention ITT population N PANSS-P scores baseline (SD) PANSS-P scores follow-up (SD) Change PANSS-P scores from baseline to follow-up (SD)
Schimmelman et al. 2007 [71] Open Label Quetiapine N=52 Quetiapine: Quetiapine: Quetiapine:
Non-RCT
12 weeks 200-800 mg   21.4 (5.2) 14.5 (7.4) -6.9 (na)
Schiz. spectrum
Most drug-naïve
12-17 years
Findling et al. 2008 [11] Double-blind RCT 6 weeks Aripiprazole 10 mg/30 mg vs placebo N=302 (100 vs 100 vs 102) Aripiprazole 10 mg: 22.1 (SD=5.0) Aripiprazole 10 mg: 14.5 (SE=0.6 i.e. SD=6.0*) Aripiprazole 10 mg: -7.6 (SE=0.6 i.e. SD=6.0*)
Schiz. 13-17 years
Aripiprazole 20 mg: 23.5 (SD=5.0) Aripiprazole 20 mg: 15.4 (SE=0.6 i.e. SD=5.9*) Aripiprazole 20 mg: -8.1 (SE=0.6 i.e. SD=5.9*)
Arango et al. 2009 [20] Open label RCT Quetiapine vs Olanzapine N=50 Quetiapine: Quetiapine: Quetiapine:
6 months (24 vs 26) 23.3 (7.3) 15.1 (4.1) -8.2 (na)
Psychotic disorders
Most drug-naïve flexible doses
12-18 years
Swadi et al. 2010 [21] Open label RCT Quetiapine up to 800 mg vs risperidone up to 6 mg N=22 na na Quetiapine:
6 weeks (11 vs 11) -9.6 (5.5)
First episode
psychosis
Below 19 years
Findling et al. 2012 [15] Double-blind RCT Quetiapine 400 mg/800 mg vs placebo N=220 (73 vs 74 vs 73) Quetiapine 400 mg: 23.3 (5.8) Quetiapine 800 mg: 23.8 (4.8) na Quetiapine 400 mg:
6 weeks Schiz. -8.6 (SE 0.7, i.e. SD=6.3*)
13-17 years Quetiapine 800 mg:
-9.3 (SE 0.6, i.e. SD=5.1*)
NCT01009047 2013 [28] Double-blind RCT Paliperidone ER 3-9 mg vs Aripiprazole 5-15 mg N=226 (112 vs 114) Aripiprazole: 22.5 (4.3) na Aripiprazole week 8:
8 weeks/26 weeks -6.2 (4.9)
Schiz. Aripiprazole week 26:
12-17 years -8.3 (6.1)
  1. Data on PANSS positive scores and standard deviations from these studies were considered in the sample size estimation of the TEA study. Weighted average of all SDs=5.48 and of change in SD=5.68. ITT=Intention-to-treat. PANNS-P=Positive and Negative Syndrome Scale – positive score. SD=standard deviation. SE=standard error. na=not available. ER=extended release formulation. vs=versus. Schiz.=Schizophrenia. *SD=SE√n.