Table 1.
Study number | Dates, locations | Study medicationb | Patients (n) by study |
---|---|---|---|
Study 1 (D1050196) 17 | May 2004–Dec 2004, | Lurasidone 80 mg/d | 86 |
Phase II | 22 U.S. sites | Placebo | 83 |
Study 2 (D1050229) 18 | Oct 2007–Dec 2008, | Lurasidone 40 mg/d | 120 |
Phase III | multinational, | Lurasidone 80 mg/d | 116 |
48 sites (21 U.S. sites) | Lurasidone 120 mg/d | 123 | |
Placebo | 122 | ||
Study 3 (D1050231) 19 | Jan 2008–June 2009, | Lurasidone 40 mg/d | 116 |
Phase III | multinational, | Lurasidone 120 mg/d | 109 |
52 sites (25 U.S. sites) | Placebo | 111 | |
Olanzapine 15 mg/dc | 119 | ||
Study 4 (D1050233) 20 | Oct 2008–June 2010, | Lurasidone 80 mg/d | 116 |
Phase III | multinational, | Lurasidone 160 mg/d | 112 |
63 sites (24 U.S. sites) | Placebo | 116 | |
Quetiapine XR 600 mg/dc | 110 |
All were 6-week, randomized, placebo-controlled, parallel-group, fixed-dose studies.
Study medication was administered in the morning with food in Studies 1-3, and in the evening with food in Study 4.
Included in the individual study to confirm assay sensitivity, but not included in this pooled analysis.