Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT02832037|
Recruitment Status : Completed
First Posted : July 13, 2016
Results First Posted : February 24, 2021
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: BI 425809 dose 1 Drug: BI 425809 dose 2 Drug: BI 425809 dose 3 Drug: BI 425809 dose 4 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||509 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia|
|Actual Study Start Date :||July 25, 2016|
|Actual Primary Completion Date :||December 27, 2019|
|Actual Study Completion Date :||January 29, 2020|
|Experimental: BI 425809 dose 1||
Drug: BI 425809 dose 1
|Experimental: BI 425809 dose 2||
Drug: BI 425809 dose 2
|Experimental: BI 425809 dose 3||
Drug: BI 425809 dose 3
|Experimental: BI 425809 dose 4||
Drug: BI 425809 dose 4
|Placebo Comparator: Placebo||
- 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 [ Time Frame: 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.
- Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment [ Time Frame: 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 [ Time Frame: 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.
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): NCT02832037
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|