Table 1 A summary of the olanzapine long-acting injection and oral olanzapine studies analyzed
Study | Dates Conducted | Primary Objective | Design | Treatments, Doses, and Regimen | N | Diagnosis and Inclusion Criteria |
|---|---|---|---|---|---|---|
OLZ LAI[9] | Jun 2004 –Apr 2005 | Efficacy vs. placebo (PANSS Total) | 2 – 7 day washout | OLZ LAI | 404 | DSM-IV schizophrenia |
8 weeks | 405 mg/4 weeks | BPRS score ≥30 (0 – 6 scale) | ||||
Randomized, | 210 mg/2 weeks | |||||
double-blind | 300 mg/2 weeks | |||||
IM placebo/2 weeks | ||||||
Oral OLZ, Study 1[14] | Oct 1991 – Nov 1996 | Efficacy vs. placebo and HAL (BPRS) | 4 – 7 day placebo lead-in | OLZ | 335 | DSM-III-R schizophrenia with acute exacerbation |
5 ± 2.5 mg/day | ||||||
6 weeks | 10 ± 2.5 mg/day | BPRS score ≥24 (0 – 6 scale) | ||||
Randomized, | 15 ± 2.5 mg/day | |||||
double-blind | HAL: 15 ± 5 mg/day | |||||
Placebo | ||||||
Oral OLZ, Study 2[15] | Nov 1991 – Feb 1997 | Efficacy vs. HAL (BPRS) | 4 – 7 day placebo lead-in | OLZ | 431 | DSM-III-R schizophrenia with acute exacerbation |
5 ± 2.5 mg/day | ||||||
6 weeks | 10 ± 2.5 mg/day | BPRS score ≥24 (0 – 6 scale) | ||||
Randomized, | 15 ± 2.5 mg/day | CGI-S score ≥4 | ||||
double-blind | 1 mg/day | |||||
HAL: 15 ± 5 mg/day | ||||||
Oral OLZ, Study 3[16] | Jul 1993 – Jan 1997 | Efficacy vs. Placebo (BPRS) | 4 – 9 day placebo lead-in | OLZ | 152 | DSM-III-R schizophrenia with acute exacerbation |
1 mg/day | ||||||
6 weeks | 10 mg/day | BPRS score ≥24 (0 – 6 scale) | ||||
Randomized, double-blind | Placebo |