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