Table 1.
Study Characteristics
| First author, year/related study, year | Duration, wk | Blinding/setting | Diseases (max illness duration/max prior AP exposure) | Age category, y | Region (country) | No. randomized/No. completed (% randomized) | Mean OLZ dose, mg (SD)/planned dose range, mg/d | Mean age (SD), y | Male/ female, % |
White/Black/Other, % | Mean illness duration, y (SD)/mean AP exposure, mo (SD) | Mean BMI at baseline, kg/m2 (SD) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Duration: ≤13 wk | ||||||||||||
| Cheng, 2019 | 8 | Open-label/combined | First-episode schizophrenia (≤3 y/<12 wk) | Adults, 18–45 |
China (China) | 168/135 (80) | 16.0 (4.9)/10-25 | 24.6 (7.8) | 51/49 | 0/0/100 | NR/NR | NR |
| Huang, 2018 | 13 | Single-blind/unknown | First-episode schizophrenia (<2 y/drug naive) | Adolescents/adults, 13–45 |
China (China) | 29/25 (86) | 17.8 (3.6)/NR | 23.8 (5.9) | 69/31 | 0/0/100 | 0.66 (0.72)/NR | 20.4 (3.1) |
| Kahn, 2018 | 6 | Double-blind/combined | First-episode schizophrenia (<2 y/<6 wk [+4 wk AMI in phase 1]) | Adults, 18–40 |
Europea | 46/39 (85) | 15.6 (6.5)/5-20 | 24.6 (5.5) | 74/26 | 93/NA/7 | 0.6 (0.55)/NR | NR |
| Li, 2012 | 6 | Open-label/mixed | First-episode schizophrenia (NS/NS) | Adults, 18–60 |
China (China) | 40/40 (100) | 19.1 (1.9)/5-20 | 23.6 (4.9) | 70/30 | 0/0/100 | 0.59 (0.21)/NR | 20.3 (2.9) |
| Lieberman, 2003/Zipursky, 2005 | 12 | Double-blind/mixed | First-episode psychosis (<5 y/<16 wk) |
Adolescents/adults, 16–40 |
Internationalb | 131/88 (67) | 9.1 (NR)/5-10/20 | 23.5 (4.6) | 79/21 | 51/37/12 | NR/1.1 (1.4) | 23.7 (4.9) |
| McEvoy, 2007/Patel, 2009 | 12 | Double-blind/mixed | First-episode psychosis (<5 y/<16 wk) |
Adolescents/adults, 16–40 |
USA (USA) | 133/85 (64) | 11.7 (5.3)/2.5-20 | 24.7 (5.8) | 76/24 | 46/46/8 | 0.92 (1.1)/1.7 (2.2) | 25.8 (6.2) |
| Ou, 2013 | 6 | Open-label/mixed | First-episode schizophrenia (<1 y/<2 wk) | Adults, 18–45 |
China (China) | 130/111 (85) | 19.0 (2.3)/5-20 | 27.7 (8.0) | 57/43 | 0/0/100 | 8.4 (4.4)/NR | 20.7 (2.8) |
| Perez-Iglesias, 2007 | 12 | Open-label/combined | First-episode psychosis (1st episode/drug naive) |
Adolescents/adults, 15–50 |
Europe (Spain) | 43/41 (95) | 14.6 (3.5)/5-20 | 28.5 (6.5) | 61/39 | NR | 1.2 (2.8)/NR | 22.9 (3.0) |
| Poyurovsky, 2002 | 8 | Double-blind/inpatient | First-episode schizophrenia (1st episode/ <4 wk) |
Adults,e NS |
Europe (Israel) | 15/13 (87) | 10.0 (NR)/10 | 26.1 (7.9) | 70/30 | NR | 2.2 (2.3)/NR | 21.1 (3.3) |
| Saddichha, 2008a/Saddichha, 2008b/Saddichha, 2008c | 6 | Double-blind/inpatient | First-episode schizophrenia (NS/drug naive) | Adults,e NS |
India (India) | 35/NR | 16.5 (4.6)/NS | NR | 51/49 | 0/0/100 | NR/NR | NR |
| Sanger, 1999 | 6 | Double-blind/inpatient | First-episode psychosis (<5 y/NS) |
Adults,e NS |
Internationalc | 59/43 (73) | 11.6 (5.9)/5-20 | 29.0 (7.8) | 68/32 | 80/10/10 | NR/NR | NR |
| Sikich, 2008 | 8 | Double-blind/unknown | Early-onset schizophrenia spectrum disorder (NS/NS) | Children/adolescents, 8–19 |
USA (USA) | 35/17 (49) | 11.4 (5.0)/2.5-20 | NR | 71/29 | 60/34/6 | NR/NR | 23.5 (4.5) |
| Wu, 2006/Wu, 2007 | 8 | Open-label/inpatient | First-episode schizophrenia (1st episode/drug naive) | Adults, 18–45 |
China (China) | 24/24 (100) | 13.7 (1.6)/10-20 | 34.2 (10.3) | 58/42 | 0/0/100 | 0.16 (0.06)/NR | 20.7 (0.3) |
| Zhang, 2014 | 8 | Unknown/combined | First-onset schizophrenia (<5 y/drug naive) | Adults, 17–60 |
China (China) | 55/50 (91) | 18.1 (3.0)/NS | 41.2 (13.3) | 68/32 | 0/0/100 | 1.95 (1.6)/NR | NR |
| Duration: >13 wk | ||||||||||||
| Arango, 2009 | 24 | Open-label/inpatient | First psychotic episode (<1 y/NS) |
Adolescents, 12–18 | Europe (Spain) | 26/16 (62) | 9.7 (6.5)/NS | 15.7 (1.4) | 77/23 | 77/0/23 | NR/NR | 21.7 (NR) |
| Findling, 2010 | 52 | Double-blind/unknown | Early-onset schizophrenia spectrum disorder (NS/NS) | Children/adolescents, 8–19 | USA (USA) | 13/3 (23) | 9.6 (5.4)/2.5-20 | NR | 92/8 | 69/23/8 | NR/NR | 21.7 (3.9) |
| Green, 2006/Zipursky, 2005 | 104 | Double-blind/mixed | First-episode psychosis (<5 y/<16 wk) |
Adolescents/adults, 16–40 |
Internationalb | 131/31 (23) | 10.2 (NR)/5-20 | 23.5 (4.6) | 79/21 | 51/37/11 | 1.0 (1.0)/1.3 (1.7) | 23.6 (4.8) |
| Kahn, 2008 | 52 | Open-label/mixed | First-episode schizophrenia and schizophreniform disorder (<2 y/<6 wk) |
Adults, 18–40 |
Europed | 105/82 (78) | 12.6 (4.7)/5-20 | 26.3 (5.9) | 64/36 | 95/NR/5 | NR/NR | 22.0 (3.0) |
| McEvoy, 2007/Patel, 2009 | 52 | Double-blind/mixed | Early psychosis (<5 y/<16 wk) | Adolescents/adults, 16–40 |
USA (USA) | 133/42 (32) | 11.7 (5.3)/2.5-20 | 24.7 (5.8) | 76/24 | 46/46/8 | 0.92 (1.1)/1.73 (2.2) | 25.8 (6.2) |
| Perez-Iglesias, 2008/Perez-Iglesias, 2009 | 52 | Open-label/mixed | First-episode psychosis (1st episode/ drug naive) |
Adolescents/adults, 15–60 |
Europe (Spain) | 54/36 (67) | 10.1 (3.9)/5-20 | 27.6 (6.9) | 59/41 | NR | 1.0 (2.45)/NR | 22.8 (2.9) |
| San, 2012 | 52 | Open-label/combined | First-episode psychosis (NR/drug naive) | Adults, ≥18 | Europe (Spain) | 25/15 (60) | 7.5 (6.3)/7.5-40 | 25.3 (6.8) | 68/32 | NR | 1.34 (3.7)/NR | 21.8 (2.9) |
Abbreviations: AMI, amisulpride; AP, antipsychotic; BMI, body mass index; max, maximum; NR, not reported; NS, not stated; OLZ, olanzapine.
*Values reported as medians.
aAustria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, Switzerland, UK.
bNorth America and Western Europe.
cNorth America and Europe.
dAustria, Belgium, Bulgaria, Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, Sweden, and Switzerland.
eAge group not reported but determined based on sample characteristics.