Table 2.
Change from baseline in global psychopathology, abnormal movements, functional status, global clinical status, and laboratory values
| Variable | N | Baseline Mean (SD) |
Endpoint Mean (SD) |
Statistic |
|---|---|---|---|---|
| CGI-BP | 53 | |||
| Severity: mania | 1.3 (0.6) | 1.4 (0.7) | t = −0.59, df = 52, p = 0.56 | |
| Severity: depression | 4.6 (0.8) | 2.4 (1.2) | t = 11.31, df = 52, p < 0.01 | |
| Severity: overall | 4.6 (0.8) | 2.5 (1.2) | t = 10.09, df = 52, p < 0.01 | |
| AIMS | 48 | 2.0 (3.7) | 1.2 (2.7) | t = 1.81, df = 47, p = 0.08 |
| Simpson Angus Scale | 48 | 0.77 (1.61) | 0.73 (1.51) | t = 0.26, df = 47, p = 0.80 |
| Barnes Akathisia Scale | 47 | 0.81 (2.28) | 0.28 (0.97) | t = 2.16, df = 46, p = 0.04 |
| SF-12 45 | ||||
| Mental score | 29.5 (10.1) | 43.5 (11.8) | t = −7.72, df = 44, p < 0.01 | |
| Physical score | 42.1 (12.9) | 41.0 (12.3) | t = 0.61, df = 44, p = 0.54 | |
| WHO-DAS II (subscales) | 47 | |||
| Getting around | 5.1 (3.0) | 4.9 (3.0) | t = 0.93, df = 46, p = 0.36 | |
| Self care | 3.5 (2.0) | 2.9 (1.8) | t = 2.93, df = 46, p < 0.01 | |
| Life activities | 2.9 (1.2) | 2.3 (1.4) | t = 2.94, df = 46, p < 0.01 | |
| Understand/communicate | 4.7 (1.9) | 3.4 (1.7) | t = 4.08, df = 46, p < 0.01 | |
| Participation in society | 6.0 (2.0) | 4.1 (2.0) | t = 6.03, df = 46, p < 0.01 | |
| Getting along with people | 4.1 (2.1) | 2.9 (1.7) | t = 3.89, df = 46, p < 0.01 | |
| Physical parameters | ||||
| Body weight (lbs) | 52 | 196.7 (40.7) | 197.6 (40.3) | t = −0.92, df = 51, p = 0.36 |
| Body weight (kg) | 89.3 (18.5) | 89.7 (18.1) | ||
| Serum glucose | 42 | 107 (43.4) | 101 (25.7) | t = 1.06, df = 41, p = 0.29 |
| Total cholesterol | 41 | 192 (55.6) | 183 (46.0) | t = 1.77, df = 40, p = 0.08 |
| Triglycerides | 42 | 168 (108.7) | 144 (91.4) | t = 1.75, df = 41, p = 0.09 |
CGI-BP = Clinical Global Impression–Bipolar version; AIMS = Abnormal Involuntary Movement Scale; SF-12 = Medical Outcomes Study Short Form General Health Survey; WHO-DAS II = WHO-Disability Assessment Schedule II.