A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
Summary
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
Timeline
- Start
- 2014-11-10
- Primary completion
- 2016-05-26
- Completion
- 2016-06-13
Outcome
Missed primary endpoint
registry BI 409306 - 10 Milligram vs Placebo; p = 0.1256; Mean Difference (Final Values) -1.2 (95% CI -2.76 to 0.34) NCT02281773 ↗
registry BI 409306 - 25 Milligram vs Placebo; p = 0.7337; Mean Difference (Final Values) 0.3 (95% CI -1.30 to 1.84) NCT02281773 ↗
registry BI 409306 - 50 Milligram vs Placebo; p = 0.6994; Mean Difference (Final Values) 0.3 (95% CI -1.31 to 1.95) NCT02281773 ↗
registry BI 409306 - 100 Milligram vs Placebo; p = 0.4270; Mean Difference (Final Values) -0.6 (95% CI -2.19 to 0.93) NCT02281773 ↗
Publications
- Dorner-Ciossek C, Kroker KS, Rosenbrock H. Role of PDE9 in Cognition. Adv Neurobiol. 2017;17:231-254. doi: 10.1007/978-3-319-58811-7_9.
- Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 498306 | Unknown | 25 mg | Oral |
| Subject | BI 498306 | Unknown | 50 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 10 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 100 mg | Oral |