7. Atypical antipsychotics versus placebo: adverse effects data that could not be used in the meta‐analyses.
| Study name | Short‐/medium‐/long‐term outcomes | Group 1 | Group 2 | Group 1 sample size | Group 2 sample size | Group 1 results Mean (standard deviation) | Group 2 results Mean (standard deviation) | Other data | Notes |
| Malone 2001 | Short‐term weight gain | Olanzapine 2.5‐2 mg/day | Placebo | Not described. 33 in total | Not described. 33 in total | Not outlined for each group. Weight gain was described as change in BMI category from baseline to endpoint and summarised as a group BMI change. AEs were measured at baseline and after week 12 (not after blinded phase) |
Not outlined for each group. See Group 1 | At baseline, 70.3% of children were at a healthy weight, 21.6% were overweight, 2.7% were obese, and 5.4% were underweight. By week 12, 42.4% were healthy weight, 21.2% were overweight, and 36.4% were obese. | |
| Marcus 2009 | Short‐term weight gain (kg) | Aripiprazole 5 mg/day | Placebo | 44 | 13 | 1.5 (2.65) | 0.4 (1.85) | "All aripiprazole treatment groups were associated with significantly greater change in weight compared with the placebo at endpoint. Aripiprazole 5 mg/day and aripiprazole 15 mg/day were associated with a greater prevalence of clinically significant weight gain than the placebo, and aripiprazole 15 mg/day was also associated with significantly greater increases in body mass index than the placebo" | Skewed |
| Aripiprazole 10 mg/day | Placebo | 49 | 13 | 1.4 (2.1) | 0.4 (1.85) | ||||
| Aripiprazole 15 mg/day | Placebo | 47 | 13 | 1.6 (2.06) | 0.4 (1.85) | ||||
| Owen 2009 | Short‐term weight gain (kg) | Aripiprazole (2‐15 mg/day) |
Placebo | 47 | 50 | 2.0 (12.15) | 0.8 (12.15) | "Aripiprazole treatment was associated with significantly greater mean weight change compared with placebo at endpoint (LOCF: 2.0 vs 0.8 kg (P .005); observed case: 1.9 vs 0.5 kg (P .01)). Aripiprazole was also associated with a greater incidence of clinically significant weight gain (>7% increase from baseline) than placebo (LOCF: 28.9% vs 6.1%; P.01)" | Skewed |
| AE: adverse effect; BMI: body mass index; LOCF: Last observation carried forward | |||||||||