This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
Summary
This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities. Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer. The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.
Timeline
- Start
- 2019-04-15
- Primary completion
- 2022-09-30
- Completion
- 2022-11-04
Outcome
Missed primary endpoint
registry BI 425809 10 mg + Computerized Cognitive Training vs Placebo + Computerized Cognitive Training; p = 0.3101 NCT03859973 ↗
registry Mean Difference (Net) -0.866 (95% CI -2.605 to 0.833); Mixed Models Analysis NCT03859973 ↗
paper At efficacy endpoint assessment, no differences were observed between treatment groups. PMID 39759424 ↗
Publications
- Harvey PD, McDonald S, Fu E, Reuteman-Fowler C. Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia. Schizophr Res Cogn. 2024 Dec 14;40:100340. doi: 10.1016/j.scog.2024.100340. eCollection 2025 Jun.
- Harvey PD, Bowie CR, McDonald S, Podhorna J. Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial. Clin Drug Investig. 2020 Apr;40(4):377-385. doi: 10.1007/s40261-020-00893-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 425809 | Unknown | 10 mg | — |