Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Phase 2

Completed

Interventions: Drug: BI 425809 dose 1
Drug: BI 425809 dose 2
Drug: BI 425809 dose 4
Drug: BI 425809 dose 3
Drug: Placebo

Brief Summary: The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment	Baseline, after 6 and 12 weeks of treatment	MCCB overall composite T-score was derived from scores of 7 cognitive domains (Speed of Processing, Verbal Learning, Working Memory, Reasoning and Problem Solving, Visual Learning, Social Cognition, Attention) obtained from a total of 10 tests (Trail Making, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning, Wechsler Memory Scale, Letter-Number Span, Neuropsychological Assessment Battery, Brief Visuospatial Memory, Category Fluency, Mayer-Salovey-Caruso Emotional Intelligence, Continuous Performance) and ranges typically between -20 and +99, a larger T-score indicates better cognition. Change from baseline in MCCB overall composite T-score after 12 weeks of treatment was modeled using a MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (week 6 and week 12 of treatment) as repeated measures, subject as random effect, adjusted mean (standard error) after 12 weeks of treatment is reported.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment	Baseline and after 12 weeks of treatment	SCoRS total score was derived as the sum of non-missing responses from 20 interview-based items rated by an interviewer on a 4-point scale. A response of "not available" to an item was treated as missing. If six or more of the 20 items were missing for a participant at a visit, then the corresponding SCoRS total score was missing for that participant at the visit. If five or less of the 20 items were missing for a participant at a visit, then the item(s) with missing value(s) were imputed first with the average of the non-missing item values, then the SCoRS total score for the participant at the visit was derived as the sum of non-missing item values and the imputed item values. SCoRS total score is between 20 and 80 where higher score values represent greater degree of impairment in day-to-day functions due to cognitive deficits. Analysis of covariance model was fitted to calculate adjusted mean and standard error, model details in the Statistical Analysis section.
Percentage of Participants With Any Adverse Event	On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days	Percentage of participants with any Adverse Event.

Locations (81): Collaborative Neuroscience Network, LLC (CNS)
🇺🇸
Garden Grove, California, United States
Synergy San Diego
🇺🇸
Lemon Grove, California, United States
NRC Research Institute
🇺🇸
Orange, California, United States
Alliance for Wellness
🇺🇸
Panorama City, California, United States
CNRI - Los Angeles
🇺🇸
Pico Rivera, California, United States
CNRI-San Diego, LLC
🇺🇸
San Diego, California, United States
Premier Clinical Research Institute
🇺🇸
Miami, Florida, United States
Synexus
🇺🇸
Atlanta, Georgia, United States
Atlanta Center
🇺🇸
Atlanta, Georgia, United States
Uptown Research Institute
🇺🇸
Chicago, Illinois, United States
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Collaborative Neuroscience Network, LLC (CNS)
🇺🇸Garden Grove, California, United States