Table 3.
Randomized double-blind trials of DRPAs in mood disorders.
| Indication | Aripiprazole | Brexpiprazole | Cariprazine |
|---|---|---|---|
| Bipolar disorder manic/mixed episode |
6 RCTs vs. placebo (monotherapy):
responses (3 W): 47.7 vs. 31.4%. NNT = 6 remissions (3 W): 39.6 vs. 32.4%. NNT = 14 |
2 RCTs vs. placebo: reduction in YMRS: LSMD = 0.14 (95% CI −1.74, 2.03) (n.s.) LSMD = −1.62 (95% CI −3.56, 0.32) (n.s.) |
3 RCTs vs. placebo: responses: 57% vs. 36%. OR = 2.30 (95% CI 1.78, 2.98), NNT = 5, p < 0.001 remissions: 46% vs. 30%. NNT = 7. p < 0.001 |
| Bipolar disorder depressive episode |
2 RCTs vs. placebo: negative results | n/a |
4 RCTs vs. placebo: reduction in MADRS: 1.5 mg/day SMD = −0.26 (95% CI −0.49, −0.02) 3 mg/d SMD = −0.21 (95% CI −041, −0.01) remissions: NNT = 10 (1.5 mg); NNT = 14 (3 mg) |
| Bipolar disorder maintenance treatment |
ARI oral 1 RCT monotherapy vs. placebo: 26 W time to relapse: p = 0.020 number of relapses 25 vs. 43% (p = 0.013) 100 W time to relapse: p = 0.011 1 RCT adjuvant therapy: time to relapse of mania: p < 0.01 |
n/a |
1 RCT vs. placebo: results not available |
|
ARI LAI 1 RCT vs. placebo: time to relapse: p < 0.0001 number of relapses: 26.5 vs. 51.1% (p < 0.0001) |
|||
| Bipolar disorder acute agitation |
ARI im 1 RCT vs. placebo responses: 66 vs. 37%. NNT = 3 |
n/a | n/a |
| Bipolar disorder children and adolescents |
4 RCTs vs. placebo: response in acute mania: p < 0.01 relapse prevention: p < 0.05 |
n/a | n/a |
| Unipolar depression adjunctive treatment |
3 RCTs vs. placebo: reduction in MADRS: −10.3 vs. −6.5; p < 0.0001 responses: 36 vs. 19%, NNT = 6 remissions: 24 vs. 12%, NNT = 8 |
9 RCTs vs. placebo: reduction in MADRS: SMD = −0.20; (95% CI −0.29, −0.11) responses: NNT = 17 remissions: NNT = 25 |
5 RCTs vs. placebo: 1 positive study (2.5–4/day mg: change in MADRS p = 0.01; responses: NNT = 9) 2 negative studies 2 studies: no results available |
| Unipolar depression elderly patients |
2 RCTs vs. placebo: well tolerated, no efficacy data |
n/a, no studies available; ARI, aripiprazole; ARI LAI/ALAI, aripiprazole long-acting injectable; ARI im, aripiprazole intramuscular injection; ARI oral, aripiprazole oral formulation; LSMD, least squares mean difference; MADRS, Montgomery–Asberg Depression Rating Scale; NNT, number needed to treat; n.s., no significant difference; OR, odds ratio; RCT, randomized controlled trial; PL, placebo; SMD, standardized mean difference; W, week; YMRS, Young Mania Rating Scale.