Table 1.
Relapse prevention study characteristics
| Study | Stabilization | Stability criteriab | Number of DB patients |
DB length (weeks) | |
|---|---|---|---|---|---|
| Design | Length (weeks)a | ||||
| Asenapine27 | OL | 26 | 26 weeks continuous | ASE=194 PBO=192 |
26 |
| Brexpiprazole23 | SB | 12–40 | 12 weeks continuous | BRX=97 PBO=105 |
<52c |
| Cariprazine20 | OL | 20 | Meet at weeks 8 and 20 | CAR=101 PBO=99 |
26–72 |
| Iloperidone28 | OL | 15–25 | 12 weeks continuous | ILO=153 PBO=150 |
<26c |
| Lurasidone26 | OL | 12–24 | 12 weeks continuous | LUR=144 PBO=141 |
28 |
| Olanzapine25 | OL | 8–14 | 8 weeks continuous | OLZ=224 PBO=102 |
<30c |
| Paliperidone ER29 | OL | 14 | Meet at weeks 8 and 14e | PAL=105 PBO=102 |
16–40c |
| Quetiapine XR24,d | OL | 16 | Meet at weeks 8 and 16 | QTP=94 PBO=103 |
≤39c |
Notes: aLength includes cross-titration, run-in, and stabilization periods, if applicable, and ranges indicate that patients could move to randomization phase once stability criteria were met; bdetails on stability criteria are provided in Table S1; cvariable length is due to positive interim results and subsequent early study termination; dQTP XR was the only study that had a tapered discontinuation protocol (4-day cross titration); estability criteria obtained from https://clinicaltrials.gov/ct2/show/NCT00086320.
Abbreviations: ASE, asenapine; BRX, brexpiprazole; CAR, cariprazine; DB, double-blind; ER or XR, extended release; ILO, iloperidone; LUR, lurasidone; OL, open-label; OLZ, olanzapine; PAL, paliperidone; PBO, placebo; QTP, quetiapine; SB, single-blind.