Table 1.
Summary of study results
| Variable | ||
|---|---|---|
| Baseline characteristics (FAS, n = 134) | Male | 42 (31.34) |
| Age, years | 32.31 ± 12.34 | |
| Family history | 33 (24.63) | |
| Body mass index, kg/m2 | 23.16 ± 4.33 | |
| Disease duration, months | 71.43 ± 81.44 | |
| Previous treatment for schizophrenia | 68 (50.75%) | |
| Treatment exposure | Mean daily dose aripiprazole during 12-week study duration, ml | 19.65 ± 4.04 |
| Target dose, ml | 21.27 ± 4.63 | |
| Average time to reach target dose, days | 11.76 ± 10.39 | |
| Use of concomitant medicationa | 126 (94.03) | |
| Effectiveness | ≥ 50% decrease in PANSS total score, week 8 | 58 (43.28) |
| CGI-I improvement, week 8 | 111 (82.84) | |
| Safety | Adverse event | 75 (55.97) |
| Serious adverse event | 1 (0.75) | |
| Adverse drug reactions | 45 (33.58) | |
| Extrapyramidal syndrome | 13 (9.70) | |
| Gastrointestinal disorders: nausea and constipation | 13 (9.70) | |
| Palpitation | 10 (7.46%) | |
| Dyslipidemia | 3 (2.24) | |
| Dysfunction of liver | 2 (1.49) | |
| Agitation | 2 (1.49) |
Data are reported as n (%) or mean ± SD. SD, standard deviation. FAS, full analysis set. PANSS, Positive and Negative Syndrome Scale
CGI-I, Clinical Global Impression-Improvement. CGI-I improvement is defined as a score of 1–3
aConcomitant medications were used to implement a cross-titration strategy in the first two weeks, improve insomnia symptoms, manage adverse reactions, treat other comorbidities in patients