drugset / Trial / NCT01821378
Lurasidone Low-Dose - High-Dose Study Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
Timeline
- Start
- 2013-05
- Primary completion
- 2014-06
- Completion
- 2014-06
Outcome
Mixed primary results
registry analysis (superiority or other test); Lurasidone 20 mg vs Placebo; p = 0.255; Least Square Mean Difference -3.1 (95% CI -8.4 to 2.2); Mixed Models Analysis NCT01821378 ↗
registry analysis (superiority or other test); Lurasidone 80-160 mg vs Placebo; p <-0.001; Least Square Mean Difference -10.3 (95% CI -14.9 to -5.7); Mixed Models Analysis NCT01821378 ↗
Publications
- Loebel A, Silva R, Goldman R, Watabe K, Cucchiaro J, Citrome L, Kane JM. Lurasidone Dose Escalation in Early Nonresponding Patients With Schizophrenia: A Randomized, Placebo-Controlled Study. J Clin Psychiatry. 2016 Dec;77(12):1672-1680. doi: 10.4088/JCP.16m10698.
- Loebel A, Citrome L, Correll CU, Xu J, Cucchiaro J, Kane JM. Treatment of early non-response in patients with schizophrenia: assessing the efficacy of antipsychotic dose escalation. BMC Psychiatry. 2015 Oct 31;15:271. doi: 10.1186/s12888-015-0629-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lurasidone | Small molecule | 20 mg | — |
| Subject | Lurasidone | Small molecule | 80 mg | — |
| Subject | Lurasidone | Small molecule | 160 mg | — |