Table 1.
Patient disposition, baseline demographic, disease and treatment characteristics
| Population | |
|---|---|
| Safety population, n (%) | 116 (100) |
| Demographics | |
| Age, mean (SD), years | 37.4 (11.3) |
| Men, n (%) | 69 (59.5) |
| Weight, mean (SD), kg | 84.6 (20.2) |
| BMI, mean (SD), kg/m2 | 27.5 (6.2) |
| Schizophrenia characteristics | |
| Duration of illness, mean (SD), years | 8.4 (7.0) |
| Schizophrenia diagnosis, n (%) | |
| Paranoid schizophrenia | 82 (70.7) |
| Simple schizophrenia | 15 (12.9) |
| Other schizophrenia | 10 (8.6) |
| Previous antipsychotic therapy | |
| Inclusion reasons, n (%)a | |
| Insufficient effectiveness | 94 (81.0) |
| Severe adverse effects | 36 (31.0) |
| Patient desire | 77 (66.4) |
| Signs of ineffectiveness, n (%)a | |
| Inadequate control of positive symptoms | 35 (30.2) |
| Inadequate control of negative symptoms | 103 (88.8) |
| Inadequate control of affective symptoms | 46 (39.7) |
| Inadequate control of cognitive symptoms | 58 (50.0) |
| Type of antipsychotic taken by >10% of patients within the last month before study entry, n (%) | |
| Quetiapine | 38 (32.8) |
| Olanzapine | 24 (20.7) |
| Haloperidol | 23 (19.8) |
| Aripiprazole | 22 (19.0) |
| Risperidone | 19 (16.4) |
| Clozapine | 14 (12.1) |
| Amisulpride | 12 (10.3) |
| Non-antipsychotic therapy within the last month before study entry, n (%) | |
| Benzodiazepines | 33 (28.5) |
| Antidepressants | 46 (39.7) |
| Anti-EPS medication | 57 (49.1) |
| Mood stabilizers | 23 (19.8) |
| Sleeping agents | 4 (3.5) |
| Cariprazine therapy | |
| Scheme of therapy change, n (%) | |
| Abrupt discontinuation | 45 (38.8) |
| Cross-titration | 71 (61.2) |
| Starting dose, n (%), mg/day | |
| 1.5 | 101 (87.1) |
| 3.0 | 9 (7.8) |
| 4.5 | 2 (1.7) |
| 6.0 | 4 (3.5) |
| Maintenance dose at termination of study, n (%), mg/day | |
| 1.5 | 13 (11.2) |
| 3.0 | 32 (27.6) |
| 4.5 | 33 (28.5) |
| 6.0 | 35 (30.2) |
| 7.5b | 3 (2.6) |
| Patient disposition | |
| Completed study, n (%) | 96 (82.8) |
| Premature discontinuation, n (%) | 20 (17.2) |
| Reasons for premature discontinuation, n (%)a | |
| Ineffective therapeutic response | 4 (20.0) |
| Treatment-emergent adverse events | 9 (45.0) |
| Withdrawal of consent | 10 (50.0) |
| Other | 6 (30.0) |
a
Categories are not mutually exclusive.
b
Not according to summary of product characteristics (SmPC), protocol violation.