Table 2.
Open-label studies.
| Study | Study type | Subjects recruited | Subjects completed | Study description | Inclusion criteria | Compared drugs (mg/day) | Primary efficacy measures | Definition of clinical response | Response rate | Completion rate | Conclusion |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Dursun et al. 33 | Open label | n = 16 | n = 16 | 16 weeks Outpatients |
TRS | Olanzapine (up to 40) | BPRS | At least 20% reduction in BPRS score | 50% | 100% | Significant overall improvement, but difference between high + standard dose not statistically significant |
| Lindenmayer et al. 34 | Open label | n = 43 | n = 27 | 14 weeks Inpatients |
TRS or TR SZA | Olanzapine (up to 40) | PANSS BPRS CGI |
At least 20% reduction in BPRS
score Plus: Endpoint CGI score of 3 or less, or Endpoint BPRS score of 35 or less |
16.7% | 62.8% | Olanzapine was associated with a modest, non-significant improvement |
| Chiu et al. 35 | Open label | n = 51 | n = 43 | 13 weeks Outpatients |
TRS | Olanzapine (up to 25) | PANSS BPRS CGI |
At least 20% reduction in BPRS score Plus: A CGI S score of 3 or less |
39.2% | 84.3% | Significant improvement in positive and negative
symptoms HDO was generally well tolerated |
| Kishi et al. 36 | Open label | n = 13 | n = 4 | 24 weeks Inpatients |
TRS | Olanzapine (up to 40) | PANSS | 10% or greater reduction in PANSS score | 30.8% | 30.8% | Improvements on PANSS scores not statistically significant |
BPRS, Brief Psychiatric Rating Scale; CGI, Clinical Global Impression; HDO, high-dose olanzapine; PANSS, Positive and Negative Syndrome Scale; TRS, treatment-resistant schizophrenia; TR SZA, treatment-resistant schizoaffective disorder.