Table 1.
Demographics and key baseline characteristics (13-week acute treatment phase) and medication adherence distribution and summary of long-acting injectable antipsychotic (LAI) antipsychotic usage (one-year observational follow-up phase).
| Characteristics | Total (n=362) |
|---|---|
| 13-week acute treatment phase | |
| Age, mean (SD), years | 31.4 (10.75) |
| Sex, n (%) | |
| Men | 196 (54.14) |
| Body weight, mean (SD), kg | 64.4 (12.56) |
| BMI, mean (SD), kg/m2 | 23.3 (3.76) |
| Duration of schizophrenia, mean (SD), years | 4.9 (5.25) |
| Duration distribution of disease, n (%) | |
| ≤5 years | 237 (65.47) |
| >5 years | 125 (34.53) |
| PANSS total score, mean (SD) | |
| Baseline | 90.5 (12.04) |
| Week-13 acute phase | 48.9 (10.22) |
| CGI-S score, mean (SD) | |
| Baseline | 5.2 (0.73) |
| Week-13 acute phase | 2.7 (0.84) |
| PSP score, mean (SD) | |
| Baseline | 46.0 (13.53) |
| Week-13 acute phase | 70.7 (8.21) |
| One-year observational follow-up phase | |
| Degree of adherence to antipsychoticsa, n (%) | |
| 0% | 35 (9.7) |
| <80% | 39 (10.8) |
| ≥80% | 288 (79.6) |
| LAI usageb in patients with >0% adherence, n (%) | n=327 |
| PP1M | |
| No use | 205 (62.7) |
| Interrupted use | 35 (10.7) |
| Continued use | 87 (26.6) |
| All LAIc | |
| No use | 193 (59.0) |
| Interrupted use | 36 (11.0) |
| Continued use | 98 (30.0) |
BMI: body mass index; CGI-S: Clinical Global Impressions-Severity; PANSS: Positive and Negative Syndrome Scale; PSP: Personal and Social Performance Scale; SD: standard deviation.
Adherence to all antipsychotics (%)=exposure duration of all antipsychotics (days)/time to the first relapse (days) or study completion/withdrawal (days)×100. For patients on LAI antipsychotics, the last dose in the acute phase was considered to provide continued exposure during the interval between last dose and the next scheduled dose. For example, the actual exposure duration for PP1M in this analysis was calculated as the date of last injection in the acute phase+30 days. Time to the first relapse was determined as the time from the start date to the first relapse recorded.
The usage of PP1M/all LAI antipsychotics was categorized according to the percent of PP1M/all LAI antipsychotic exposure duration in all antipsychotics exposure duration during the observational follow-up phase; 0% usage was defined as “no use;” 0–100% usage as “interrupted use;” and 100% usage as “continued use.”
PP1M and/or other LAI antipsychotics.