Table 2.
Randomized double-blind trials of DRPAs in schizophrenia.
| Indication | Aripiprazole | Brexpiprazole | Cariprazine |
|---|---|---|---|
| Acute treatment (overall symptom change) |
ARI oral 27 RCTs vs. placebo: SMD = −0.41 (95% CI −0.32, −0.50) Registration studies: NNT = 8 (95% CI 6, 13) 4 RCTs vs. risperidone: n.s. (SMD = −0.07; 95% CI −0.35, −0.20) 4 RCTs vs. olanzapine: n.s. (SMD = −0.15; 95% CI −0,32, 0.02) 1 RCT vs. ziprasidone: n.s. (SMD = −0.16; 95% CI 0.50, 0.18) 3 RCTs vs. haloperidol: n.s. (SMD = 0.00; 95% CI −0.24, 0.23) ARI LAI 2 RCTs vs. placebo: ALAI monohydrate: p < 0.0001 ALAI lauroxil: p < 0.001 |
6 RCTs vs. placebo: SMD = −0.26 (95% CI −0.12, −0.39) NNT = 7 (95% CI 5, 12) |
4 RCTs vs. placebo: SMD = −0.34 (95% CI −0.20, −0.49) NNT = 10 (95% CI 7, 18) |
| Relapse prevention |
ARI oral 1 RCT vs. placebo: time to relapse: p < 0.001 HR: 0.59 (95% CI 0.35. 0.71) relapses: 34% vs. 57% (p < 0.001) 2 RCTs vs. haloperidol: time to relapse: p = 0.0001 HR: 0.81 (95% CI 0.57. 1.14) relapses/treatment failures: 17% vs. 21% |
1 RCT vs. placebo: time to relapse: p < 0.0001 HR: 0.292 (95% CI 0.156. 0.548) impending relapses: 13.5% vs. 38.5% (p < 0.0001) |
1 RCT vs. placebo: time to relapse: p = 0.001 HR: 0.45 (95% CI 0.28, 0.73), NNT = 5 relapses: 24.8% vs. 47.5% |
|
ARI LAI 1 RCT vs. placebo: time to relapse: p < 0.0001 HR (PL/ALAI): 5.03 (95% CI 3.15, 8.02) impending relapses: 10.0% vs. 39.6% 2 RCTs vs. ARI oral (= noninferiority) |
|||
| Acute agitation |
ARI im 2 RCTs vs. placebo: ARI 5.25 mg: p ≤ 0.05 ARI 9.75 mg: p < 0.001 responses: 55% vs. 36%. NNT = 5 |
n/a | n/a |
| Children and adolescents |
1 RCT vs. placebo: ARI 10 mg: p = 0.05; remission NNT = 6 ARI 30 mg: p = 0.007; remission NNT = 5 |
n/a | |
| Predominant negative symptoms | n/a | n/a |
1 RCT vs. risperidone: LSMD in PANSS-FSNS: −1.46 (95% CI −2.39, −0.53), p < 0.01 responses: 69% vs. 58%; NNT = 9 |
| Treatment-refractory patients |
Clozapine augmentation 7 RCTs vs. placebo: total symptoms: SMD = −0.57 (95% CI −1.02, −0.13) |
n/a | n/a |
n/a, no studies available; ARI, aripiprazole; ARI LAI/ALAI, aripiprazole long-acting injectable; ARI im, aripiprazole intramuscular injection; ARI oral, aripiprazole oral formulation; HR, hazard ratio; LSMD, least squares mean difference; NNT, number needed to treat; n.s., no significant difference; PANSS, Positive and Negative Syndrome Scale; PANSS-FSNS, PANSS-factor score for negative symptoms; RCT, randomized controlled trial; PL, placebo; SMD, standardized mean difference.