NCT03859973

This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia

A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	BI 425809	Tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2019-04-15
• Primary completion: 2022-09-30
• Completion: 2022-11-04
• First posted: 2019-03-01
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

50 sites across 6 countries: United States, Australia, Canada, France, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study