Table 1.
Comparing the BOLDER studies
| BOLDER I
|
BOLDER II
|
|||||
|---|---|---|---|---|---|---|
| Placebo | Seroquel-300 | Seroquel-600 | Placebo | Seroquel-300 | Seroquel-600 | |
| N | 181 | 181 | 180 | 168 | 172 | 169 |
| DSM-IV diagnosis | ||||||
| BP 1 (%) | 66.3 | 67.4 | 67.1 | 68.3 | 67.1 | 66.9 |
| BP II (%) | 33.7 | 32.6 | 32.9 | 31.7 | 32.9 | 33.1 |
| RCBD | 20.7 | 24.4 | 18.2 | 32.9 | 28.4 | 30.5 |
| mean age | 38.3 | 36.6 | 37.3 | 37.7 | 37.2 | 38.2 |
| sex (%) | ||||||
| male | 37.9 | 45.9 | 41.8 | 39.8 | 44.5 | 45 |
| female | 62.1 | 54.1 | 58.2 | 60.2 | 55.5 | 55 |
| baseline scores | ||||||
| MADRS | 30.6 | 30.4 | 30.3 | 29.6 | 31.1 | 29.9 |
| HAM-D | 24.6 | 24.5 | 24.7 | 24.3 | 24.9 | 24.3 |
| CGI | 4.4 | 4.4 | 4.5 | 4.5 | 4.6 | 4.4 |
| Mean change in score | ||||||
| MADRS | −10.26 | −16.39 | −16.73 | −11.93 | −16.94 | −16 |
| HAM-D | −8.54 | −13.38 | −13.84 | −9.92 | −13.81 | −12.97 |
| CGI | 2.97 | 2.27 | 2.37 | 2.88 | 2.28 | 2.29 |
| Response rates | 36.10% | 58% | 58% | 44.70% | 60.00% | 58.30% |
| Remission rates | 28.40% | 52.90% | 52.90% | 37.30% | 51.60% | 52.30% |
| Effect size in BP I | 0.91 | 1.09 | 0.67 | 0.51 | ||
| Effect size in BP II | 0.28 | 0.39 | 0.56 | 0.64 | ||
Abbreviations: BP, bipolar; CGI, Clinical Global Impression; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, fourth edition; HAM-D, Hamilton depression rating scale; MADRS, Montgomery-Åsberg Depression Rating Scale scores; RCBD, rapid cycling bipolar disorder.