Table 1.
Aripiprazole for the treatment of schizophrenia, randomized clinical trials
| Reference | Duration (weeks) | N | Aripiprazole, dose, N | Comparators, dose, N | Comments |
|---|---|---|---|---|---|
| Marder et al 2003 | 4 | 103 | 5–30 mg (N=34) | Placebo (N=35), haloperidol 5–20 mg (N=34) | Phase II study reported in a pooled safety analysis |
| Marder et al 2003 | 4 | 307 | 2 mg (n=59), 10 mg (N=60), 30 mg (N=61) | Placebo (N=64), haloperidol 10 mg (N=63) | Phase II study reported in a pooled safety analysis |
| Marder et al 2003 | 4 | 305 | 20 mg (N=101), 30 mg (N=101) | Placebo (N=103) | Phase III study reported in a pooled safety analysis |
| Kane et al 2002 | 4 | 414 | 15 mg (N=102), 30 mg (N=102) | Placebo (N=106), haloperidol 10 mg (N=104) | Haloperidol did not separate from placebo on the responder analysis; included in a pooled safety analysis (Marder et al 2003) |
| Potkin et al 2003 | 4 | 404 | 20 mg (N=101), 30 mg (N=101) | Placebo (N=103), risperidone 6mg (N=99) | |
| Bristol-Myers Squibb 2001 (CN138-001) | 6 | 420 | 10 mg (N=103), 15 mg (N=103), 20 mg (N=97) | Placebo (N=107) | Conversion to open-label aripiprazole treatment at the end of week 3 for non-responders; included in a pooled safety analysis (Marder et al 2003) |
| Bristol-Myers Squibb 2005 (CN138-003) | 6 (and 140) | 703 | 15–30 mg (N=355) | Olanzapine 10–20 mg (N=348) | Not yet published |
| Saha et al 2002 | 15 days | 40 | 30 mg (N=12), 45 mg (N=7), 60 mg (N=7), 75 mg (N=7), 90 mg (N=7) | None | Safety and tolerability study; available as a poster only |
| Bristol-Myers Squibb 2004a (CN138-002) and McQuade et al 2004 | 28–52 | 317 | 15–30 mg (N=156) | Olanzapine 10–20 mg (N=161) | Safety and tolerability study; originally designed with a 12-week acute phase followed by a long-term extension phase, protocol amendment revised the endpoints to Week 26 (and 52) instead of Week 12 |
| Bristol-Myers Squibb 2004b (CN138-032) and Kane et al 2003 | 6 | 300 | 15–30 mg (N=154) | Perphenazine 8–64 mg (N=146) | Not yet published; treatment failure to olanzapine or risperidone prospectively determined |
| Pigott et al 2003 | 26 | 310 | 15 mg (N=155) | Placebo (N=155) | |
| Kasper et al 2003 | 52 | 1294 | 30 mg (N=861) | Haloperidol 10 mg (N=433) | |
| Bristol-Myers Squibb 2004c (CN138-047) | 52 (extension) | 214 | 15–30 mg (N=104) | Olanzapine 10–20 mg (N=110) | Open-label extension to Pigott et al (2003) |
| Bristol-Myers Squibb 2004d (CN138-087) and Tandon et al 2006 | 8–24 | 1599 | 10–30 mg (N=1295) | Other antipsychotic (N=304) | Open-label “Broad Effectiveness Trial with Aripiprazole” |