Table 8.
Mean Change from Baseline in Laboratory Parameters and Other Safety Findings
| Placebo | Cariprazinea | |||||
|---|---|---|---|---|---|---|
| 1.5 mg | 3 mg | 4.5 mg | 6 mg | Total 1.5–6 mg/d | ||
| Metabolic Parameters, mean (SD) | ||||||
| Cholesterol, mmol/L | 0.1 (0.8) | −0.0 (0.8) | −0.2 (4.2) | −0.1 (0.9) | −0.3 (3.7) | −0.1 (2.4) |
| HDL cholesterol, mmol/L | −0.0 (0.3) | −0.0 (0.3) | −0.0 (0.3) | −0.1 (0.6) | −0.0 (0.3) | −0.0 (0.4) |
| Fasting triglycerides, mmol/L | 0.0 (0.8) | 0.0 (1.1) | −0.1 (1.1) | −0.1 (1.0) | −0.1 (1.0) | −0.0 (1.0) |
| Fasting glucose, mmol/L | 0.3 (2.7) | 0.1 (1.0) | 0.2 (1.1) | 0.3 (1.4) | 0.2 (1.2) | 0.3 (1.2) |
| Body weight increase, kg | 0.2 (3.1) | 0.9 (2.9) | 1.3 (3.8) | 0.6 (3.4) | 0.8 (4.1) | 1.0 (3.8) |
| Clinical Laboratory Parameters, mean (SD) | ||||||
| Prolactin, ng/mL | −7.8 (28.2) | −14.7 (33.6) | −12.9 (32.0) | −11.3 (26.1) | −14.3 (38.2) | −13.0 (33.8) |
| Alanine aminotransferase, U/L | 0.5 (17.6) | 4.6 (44.3) | 4.8 (29.9) | 2.2 (19.9) | 4.4 (31.2) | 4.4 (29.0) |
| Aspartate aminotransferase, U/L | 0.2 (10.8) | 1.6 (17.9) | 1.8 (16.4) | 0.6 (12.3) | 2.6 (25.5) | 2.0 (20.2) |
| Alkaline phosphatase, U/L | −1.3 (26.3) | −3.1 (20.4) | 0.0 (14.8) | −2.2 (20.8) | −2.2 (22.9) | −1.3 (20.3) |
| Total bilirubin, umol/L | 0.6 (4.4) | 0.4 (4.4) | 0.5 (4.2) | 0.7 (4.7) | 0.4 (4.7) | 0.5 (4.5) |
| Creatine phosphokinase, U/L | 27.0 (373.8) | 54.9 (373.4) | 38.5 (346.6) | 25.2 (301.8) | 153.8 (2790) | 87.8 (1802) |
| Gamma glutamyl transferase, U/L | −0.4 (35.6) | 1.0 (20.5) | 1.9 (18.9) | −1.3 (22.1) | 0.5 (27.8) | 0.4 (23.6) |
| Cardiovascular Parameters, mean (SD) | ||||||
| Supine systolic blood pressure, mmHg | 0.5 (10.4) | 0.3 (10.1) | 0.7 (10.5) | 0.3 (10.9) | 1.5 (10.6) | 1.1 (10.7) |
| Supine diastolic blood pressure, mmHg | 0.2 (8.0) | 0.1 (7.3) | 0.4 (8.0) | 0.7 (8.5) | 0.8 (8.5) | 0.8 (8.3) |
| Supine pulse rate, bpm | 0.1 (12.5) | 0.2 (10.7) | −0.6 (11.2) | 0.3 (11.3) | −0.3 (11.6) | 0.1 (11.3) |
| Electrocardiographic Findings, mean (SD) | ||||||
| Heart rate, bpm | 0.7 (15.1) | −0.2 (14.9) | 0.3 (14.9) | 2.0 (14.8) | 2.3 (15.2) | 2.0 (14.9) |
| QRS interval, msec | 0.6 (7.4) | 0.6 (7.4) | 0.6 (7.4) | −0.1 (6.9) | 0.6 (7.5) | 0.6 (7.3) |
| PR interval, msec | −0.3 (14.0) | −1.2 (14.2) | −0.3 (14.7) | −1.0 (13.8) | −1.2 (14.5) | −0.7 (14.4) |
| QT interval, msec | −2.2 (29.7) | −1.8 (28.3) | −1.7 (29.5) | −5.9 (30.3) | −5.5 (30.3) | −4.1 (30.0) |
| QTcB interval, msec | −0.8 (22.9) | −1.6 (21.7) | −1.3 (21.7) | −1.3 (20.2) | 0.2 (22.0) | −0.0 (21.1) |
| QTcF interval, msec | −1.4 (17.8) | −1.5 (16.8) | −1.4 (17.3) | −2.9 (16.9) | −1.8 (17.2) | −1.6 (16.9) |
Notes: Only patients with baseline and at least one postbaseline measurement are included; Roll-over patients in the extension studies who received treatment other than cariprazine in the lead-in study are counted twice in the respective treatment groups, with the lead-in end of study visit used as baseline for the extension study; patients receiving placebo in the relapse prevention study double-blind period are included in the placebo category; aFor the fixed-dose studies, patients were counted to the dose level that they were randomized to; for the flexible-dose studies, modal daily doses were considered, meaning patients were counted to the dose level that they took for most of the time.
Abbreviations: HDL, high-density lipoprotein; LDL, low-density lipoprotein.