Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Drug: BI 425809 dose 1Drug: BI 425809 dose 2Drug: BI 425809 dose 4Drug: BI 425809 dose 3Drug: Placebo
- Registration Number
- NCT02832037
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 509
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 425809 dose 1 Placebo - BI 425809 dose 2 Placebo - BI 425809 dose 4 Placebo - Placebo Placebo - BI 425809 dose 1 BI 425809 dose 1 - BI 425809 dose 2 BI 425809 dose 2 - BI 425809 dose 3 Placebo - BI 425809 dose 4 BI 425809 dose 4 - BI 425809 dose 3 BI 425809 dose 3 -
- 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.
Trial Locations
- Locations (81)
North Carolina Psychiatric Research Center
🇺🇸Raleigh, North Carolina, United States
Midwest Clinical Research
🇺🇸Dayton, Ohio, United States
King's College Hospital
🇬🇧London, United Kingdom
Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Centro de Salud de San Juan
🇪🇸Salamanca, Spain
Podlassian Center of Psychogeriatry, Bialystok
🇵🇱Bialystok, Poland
Bushey Fields Hospital
🇬🇧Dudley, United Kingdom
Hospital Puerta de Hierro
🇪🇸Majadahonda (Madrid), Spain
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
EUROMEDIS Sp. z o.o., Szczecin
🇵🇱Szczecin, Poland
Therapy Centre DIALOG Sp.z o.o. S.j.
🇵🇱Warszawa, Poland
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
🇵🇱Torun, Poland
Centro de Salud Mental de Fuencarral
🇪🇸Madrid, Spain
Royal Edinburgh Hospital
🇬🇧Edinburgh, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Hospital del Mar
🇪🇸Barcelona, Spain
The Medical Arts Health Research Group
🇨🇦Vancouver, British Columbia, Canada
Taipei City Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
NCKUH
🇨🇳Tainan, Taiwan
Osrodek Badan Klinicznych CLINSANTE S.C.
🇵🇱Bydgoszcz, Poland
Non-public Health Care Psychiatric Institution MENTIS,Leszno
🇵🇱Leszno, Poland
Chiba University Hospital
🇯🇵Chiba, Chiba, Japan
Hospital of the University of Occupational and Environmental Health
🇯🇵Fukuoka, Kitakyushu, Japan
Kansai Medical University Medical Center
🇯🇵Osaka, Moriguchi, Japan
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Alliance for Wellness
🇺🇸Panorama City, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
CNRI - Los Angeles
🇺🇸Pico Rivera, California, United States
Premier Clinical Research Institute
🇺🇸Miami, Florida, United States
CNRI-San Diego, LLC
🇺🇸San Diego, California, United States
Synexus
🇺🇸Atlanta, Georgia, United States
Atlanta Center
🇺🇸Atlanta, Georgia, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Lake Charles Clinical Trials LLC
🇺🇸Lake Charles, Louisiana, United States
Mid-America Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Michigan Clinical Research Institute PC
🇺🇸Ann Arbor, Michigan, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Psychiatric and Behavioral Solutions, LLC
🇺🇸Salt Lake City, Utah, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
AKH - Medical University of Vienna
🇦🇹Vienna, Austria
Dr. Alexander McIntyre Inc.
🇨🇦Penticton, British Columbia, Canada
Chatham-Kent Clinical Trials Research Centre
🇨🇦Chatham, Ontario, Canada
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
🇩🇪Bad Homburg, Germany
IUSMM Institut Universitaire en Sante Mentale de Montreal
🇨🇦Montreal, Quebec, Canada
Praxis Dr. Volker Schumann
🇩🇪Berlin, Germany
Berufsausübungsgemeinschaft, Dr. sc. med. Alexander Schulze und Prof. Dr. med. Hagen Kunte
🇩🇪Berlin, Germany
Zentralinstitut für seelische Gesundheit
🇩🇪Mannheim, Germany
PANAKEIA Arzneimittelforschung Leipzig GmbH
🇩🇪Leipzig, Germany
Asst Santi Paolo E Carlo
🇮🇹Milano, Italy
Fujita Health University Hospital
🇯🇵Aichi, Toyoake, Japan
ASST degli Spedali Civili di Brescia
🇮🇹Concesio (BS), Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
🇮🇹Orbassano (TO), Italy
National Center for Global Health and Medicine Kohnodai Hospital
🇯🇵Chiba, Ichikawa, Japan
Kagawa University Hospital
🇯🇵Kagawa, Kita-gun, Japan
Kishiro Mental Clinic
🇯🇵Kanagawa, Kawasaki, Japan
Nara Medical University Hospital
🇯🇵Nara, Kashihara, Japan
Iwaki Clinic, Tokushima, Psychosomatic Medicine
🇯🇵Tokushima, Anan, Japan
National Center Neurology and Psychiatry
🇯🇵Tokyo, Kodaira, Japan
Showa University Karasuyama Hospital
🇯🇵Tokyo, Setagaya, Japan
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Shinjuku-ku, Japan
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
National Center for Mental Health
🇰🇷Seoul, Korea, Republic of
Wlokiennicza Med,Spec.Med.Prac,MD Tomasz Markowski,Bialystok
🇵🇱Bialystok, Poland
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
University at Buffalo, The State University of New York
🇺🇸Buffalo, New York, United States
Neurologie und Psychiatrie / Psychotherapie
🇩🇪Westerstede, Germany
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Collaborative Neuroscience Network, LLC (CNS)
🇺🇸Garden Grove, California, United States
Centre for Addiction and Mental Health (CAMH)
🇨🇦Toronto, Ontario, Canada
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Praxis Dr. Hahn, Berlin
🇩🇪Berlin, Germany
Kobe University Hospital
🇯🇵Hyogo, Kobe, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of