This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03859973|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : September 7, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: BI 425809 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||October 7, 2022|
|Estimated Study Completion Date :||November 4, 2022|
Experimental: BI 425809
Active drug treatment arm
Drug: BI 425809
Placebo drug arm
- Change from baseline in neurocognitive function as measured by the neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) [ Time Frame: Up to 12 weeks ]
- Change from baseline in cognitive function as measured by the overall MCCB composite score (including social cognition) [ Time Frame: Up to 12 weeks ]
- Change from baseline in the effect of cognitive deficit on day-to-day functioning as measured by SCoRS total score [ Time Frame: Up to 12 weeks ]Schizophrenia Cognition Rating Scale (SCoRS)
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Up to 12 weeks ]Positive and Negative Syndrome Scale (PANSS)
- Percentage of patients with (S)AEs [ Time Frame: Up to 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859973