Table 1.
Study, patient, and treatment characteristics of the included double-blind, randomized, placebo-controlled trials
| Correll et al4 (Phase III, NCT01396421) | Japan 20187 (Phase II/III, NCT01451164) | Kane 20155 (Phase III, NCT01393613) | |
|---|---|---|---|
| Patients | Experienced an acute exacerbation of psychotic symptoms and marked deterioration of usual function and would benefit from hospitalization or continued hospitalization for treatment. BPRS T score ≥40 and score of ≥4 on two or more BPRS items (hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness) | Experienced an acute exacerbation of psychotic symptoms and marked deterioration of usual function and would benefit from hospitalization or continued hospitalization for treatment. BPRS T score ≥40 and score of ≥4 on two or more BPRS items (hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness) | Experienced an acute exacerbation of psychotic symptoms and marked deterioration of usual function and would benefit from hospitalization or continued hospitalization for treatment. BPRS T score ≥40 and score of ≥4 on two or more BPRS items (hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness) |
| 14 days screening phase | Washout from previous antipsychotics (≥7 days) and prohibited concomitant medications | Washout from previous antipsychotics (≥7 days) and prohibited concomitant medications | Washout from previous antipsychotics (≥7 days) and prohibited concomitant medications |
| Countries (%) | United States (35.8), Ukraine (18.1), Romania (17.1), Serbia (11.8), Latvia (4.9), Malaysia (3.3), Japan (3.0), Poland (2.5), South Korea (2.4), and Canada (1.1) | Japan (100) | Colombia (NR), Croatia (NR), Mexico (NR), Philippines (NR), Russia (NR), Slovakia (NR), Taiwan (NR), and United States (NR) |
| Diagnosis | DSM-IV-TR diagnosis of schizophrenia confirmed by MINI | DSM-IV-TR diagnosis of schizophrenia confirmed by MINI | DSM-IV-TR diagnosis of schizophrenia confirmed by MINI |
| Number of patients (PBO/BRE2/BRE4) | 184/182/180 | 116/115/113 | 184/186/184 |
| Age (mean age ± SD: PBO/BRE2/BRE4) | 18–65 years | 18–64 years | 18–65 years |
| (39.7±10.8/39.6±10.2/40.8±11.0) | (45.0±11.9/43.3±12.0/44.1±11.9) | (39.3±10.8/36.9±10.9/38.6±11.0) | |
| % male (PBO/BRE2/BRE4) | 64.1/61.0/61.7 | 44.0/53.0/48.7 | 60.3/65.6/61.4 |
| % antipsychotic polypharmacy and high-dose prescription patientsa (PBO/BRE2/BRE4) | 1.10/0.00/2.20 | 6.20/6.20/11.0 | 0.00/0.00/0.00 |
| Mean PANSS T at baseline ± SD (PBO/BRE2/BRE4) | 95.9±11.5/95.9±13.7/94.9±12.2 | 97.2±19.3/96.6±19.2/96.4±15.7 | 94.8±13.0/96.3±12.8/95.1±12.5 |
| Result: % discontinuation rate due to all cause (PBO/BRE2/BRE4) | 40.2/31.9/32.8 | 39.7/29.6/39.8 | 35.9/30.6/29.3 |
| Result: PANSS T scoreb | BRE4 > PBO, BRE2 > PBO | BRE4 = PBO, BRE2 > PBO | BRE4 > PBO, BRE2 = PBO |
| Result: PANSS P scoreb | BRE4 > PBO, BRE2 > PBO | BRE4 = PBO, BRE2 = PBO | BRE4 > PBO, BRE2 = PBO |
| Result: PANSS N scoreb | BRE4 > PBO, BRE2 > PBO | BRE4 > PBO, BRE2 > PBO | BRE4 > PBO, BRE2 = PBO |
| Result: response rateb,c | BRE4 > PBO, BRE2 > PBO | BRE4 = PBO, BRE2 = PBO | BRE4 > PBO, BRE2 = PBO |
Notes:
Criteria of antipsychotic polypharmacy and high-dose prescription patients were administration of >3 antipsychotic agents with a mean total chlorpromazine dose equivalence of >1,000 mg/day or administration of >3 antipsychotic agents with >2 antipsychotics having a chlorpromazine dose equivalence of >600 mg/day, from 30 days prior to informed consent to the day before hospital admission.
A.B: A was superior to B, A=B: A was similar to B.
Responder was defined as a ≥30% reduction in the PANSS total score from baseline or CGI-I score of 1 (very much improved) or 2 (much improved) at week 6.
Abbreviations: BPRS T, Brief Psychiatric Rating Scale total; BRE, brexpiprazole; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision; MINI, Mini International Neuropsychiatric Interview; NR, not reported; PANSS (T, P or N), Positive and Negative Syndrome Scale (T: total, P: positive subscale, N: negative subscale); PBO, placebo.