Table 1.
Study characteristics
| Study and study duration | Patients characteristics | Total n (%Japanese) | Intervention (n) | Mean age/%female | PANSS‐T at baseline | Efficacy outcomes (primary analysis) a |
|---|---|---|---|---|---|---|
| P2‐J001 7 , 8 w DBRT | SZ (IP or OP, ICD‐10) with the following symptoms: delusion, hallucination, lack of spontaneity, neurotic condition or depression | 208 (100%) | LUR80 (65) | 42.4 ± 11.7/45.6% | 85.5 ± 21.4 | Not comparisons among the treatment groups (FAS, LOCF) b |
| LUR40 (72) | 81.7 ± 18.9 | |||||
| LUR20 (71) | 83.3 ± 19.6 | |||||
|
Higuchi 2019 1 , P3‐J056 (NCT01614899), 6 w DBRPCT [receding 3‐7 d placebo period, PLA responder were excluded (≥ 20% reduction in the PANSS‐T for the phase)] |
SZ (IP, DSM‐IV‐TR) with acute exacerbation (< 2 m). PANSS‐T ≥ 80, including a score of ≥ 4 on two or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9) at screening and baseline visits. | 457 (43.3%) | LUR80 (155) | 43.6 ± 13.8/47.4% | 101.0 ± 15.9 |
PANSS‐T: LUR80 = PLA PANSS‐P: LUR80 > PLA PANSS‐N: LUR80 = PLA PANSS‐G: LUR80 = PLA PANSS‐T: LUR40 = PLA PANSS‐P: LUR40 = PLA PANSS‐N: LUR40 = PLA PANSS‐G: LUR40 = PLA (mITT, MMRM) |
| LUR40 (150) | 42.1 ± 13.0/45.3% | 102.8 ± 16.3 | ||||
| PLA (152) | 42.6 ± 13.4/41.1% | 101.5 ± 14.1 | ||||
|
Higuchi 2019 2 , P3‐J002 (NCT00711269), 6 w DBRPCT [receding 3‐7 d placebo period, PLA responder were excluded (≥ 20% reduction in the PANSS‐T for the phase)] |
SZ (IP, DSM‐IV) with acute exacerbation. PANSS‐T ≥ 70, including a score of ≥ 4 on one or more of the seven positive symptom subscale items in the PANSS at screening and baseline visits. | 460 (49.5%) | LUR80 (131) | 45.7 ± 13.51/36.4% | 92.2 ± 15.3 |
PANSS‐T: LUR80 = PLA PANSS‐P: LUR80 = PLA PANSS‐N: LUR80 = PLA PANSS‐G: LUR80 = PLA PANSS‐T: LUR40 = PLA PANSS‐P: LUR40 = PLA PANSS‐N: LUR40 = PLA PANSS‐G: LUR40 = PLA (FAS, LOCF) |
| LUR40 (131) | 45.6 ± 14.48/40.0% | 91.9 ± 16.8 | ||||
| RIS4 (65) | 44.8 ± 12.59/45.3% | 88.9 ± 13.7 | ||||
| PLA (133) | 46.0 ± 12.85/44.2% | 92.8 ± 14.7 | ||||
|
P3‐J066 3 (EU‐CTR 2016‐000 060‐42), 6 w DBRPCT [receding 3‐7 d placebo period, PLA responder were excluded (≥ 20% reduction in the PANSS‐T for the phase)] |
SZ (IP, DSM‐IV‐TR) with acute exacerbation (< 2 m). PANSS‐T ≥ 80, including a score of ≥ 4 on two or more of the following PANSS items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9) and CGI‐S ≥ 4 at screening and baseline visits. | 483 (22.2%) | LUR40 (247) | 41.0 ± 11.0/51.4% | 102.8 ± 11.04 |
PANSS‐T: LUR40 > PLA PANSS‐P: LUR40 > PLA PANSS‐N: LUR40 > PLA PANSS‐G: LUR40 > PLA (ITT, MMRM) |
| PLA (236) | 39.3 ± 11.44/48.5% | 101.7 ± 11.45 |
ITT: defined all subjects who were randomized at baseline, received at least 1 dose of double‐blind study drug, and had both baseline and at least one postbaseline assessment of PANSS total score.
mITT: the same as the ITT population but excluded data from PANSS assessments that were performed within 12 hours after the use of lorazepam or hypnotic drugs.
LOCF: the most recently observed outcome measure is assumed to hold for all subsequent outcome assessment times.
MMRM: data collected from all patients (those who drop out as well as those who complete the study) are used to predict mean longitudinal outcomes for the treatment group.
FAS: In P2‐J001, defined subjects who were randomized and received at least one dose of study medication, excluded subjects who were not discontinued prior other antipsychotics, carbamazepine, sodium valproate and lithium carbonate, and had not at least one BPRS or PANSS assessments during the treatment period. In P3‐J002, defined subjects who were randomized and received at least one dose of study medication during the treatment period, and received PANSS assessments at baseline and at least once postbaseline during the treatment period.
BPRS: Brief Psychiatric Rating Scale, CGI‐S: Clinical Global Impression‐Severity of Illness, DBRPCT: double‐blind, randomized, placebo‐controlled trial, DBRT: double‐blind, randomized trial, DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, DSM‐IV‐TR: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, FAS: full analysis set, IP: inpatient, ITT: intent‐to‐treat, LOCF: last observation carried forward, LUR: lurasidone, m: month, mITT; modified intent‐to‐treat, MMRM: mixed model for repeated measurements, OP; outpatient, P2: phase II trial, P3: phase III trial, PANSS: Positive and Negative Syndrome Scale (‐T; total score, ‐P; positive subscale score, ‐N; negative subscale score, ‐G; general psychopathology subscale score), PLA: placebo, RIS: risperidone, SZ: schizophrenia
Primary outcome was underlined.
The primary outcomes were change from baseline in BPRS and PANSS total score (as a dose‐response evaluation by the maximum contrast method)