CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
- Registration Number
- NCT04860830
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called iclepertin improves learning and memory in people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.
During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.
Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 609
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iclepertin treatment group BI 425809 - Placebo group Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB) After 26 weeks of treatment MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
- Secondary Outcome Measures
Name Time Method Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Up to week 26 Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London Up to week 26 Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score After 26 weeks of treatment SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score Up to week 24 PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.
Trial Locations
- Locations (110)
Sunwise Clinical Research-Walnut Creek-70166
🇺🇸Walnut Creek, California, United States
Synexus Clinical Research-Atlanta-67262
🇺🇸Atlanta, Georgia, United States
Hassman Research Institute-Berlin-60540
🇺🇸Berlin, New Jersey, United States
LinQ Research, LLC-Richmond-70076
🇺🇸Richmond, Texas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
CNRI - Los Angeles
🇺🇸Pico Rivera, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Advanced Medical Research Group Inc
🇺🇸Hollywood, Florida, United States
Accel Research Sites Network
🇺🇸Maitland, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Ivetmar Medical Group, LLC
🇺🇸Miami, Florida, United States
Nova Psychiatry Inc.
🇺🇸Orlando, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Center for Behavioral Health, LLC
🇺🇸Gaithersburg, Maryland, United States
Arch Clinical Trials, LLC
🇺🇸Saint Louis, Missouri, United States
Omaha Insomnia and Psychiatric Services
🇺🇸Omaha, Nebraska, United States
UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
🇺🇸Raleigh, North Carolina, United States
Midwest Clinical Research
🇺🇸Dayton, Ohio, United States
Rivus Wellness and Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Oasis Life Care
🇺🇸State College, Pennsylvania, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Clínica Privada Banfield
🇦🇷Banfield, Argentina
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
🇦🇷Caba, Argentina
Fundación FunDaMos para la asistencia e investigación en psiquiatría
🇦🇷Caba, Argentina
CEN (Centro Especializado Neurociencias)
🇦🇷Cordoba, Argentina
Instituto Médico DAMIC S.R.L.
🇦🇷Cordoba, Argentina
Instituto Modelo de Neurología Lennox
🇦🇷Córdoba, Argentina
Instituto de Neurociencias San Agustín
🇦🇷La Plata, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Argentina
Centro Medico Luquez
🇦🇷San Vicente, Argentina
AKH - Medical University of Vienna
🇦🇹Vienna, Austria
CUP Vivalia -La Clairière
🇧🇪Bertix, Belgium
Sint-Kamillus
🇧🇪Bierbeek, Belgium
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
🇧🇪Duffel, Belgium
Meclinas
🇧🇪Mechelen, Belgium
Ruschel Medicina e Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
Clínica Viver - Centro de Desospitalização Humana
🇧🇷Sao Paulo, Brazil
Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry
🇧🇬Plovdiv, Bulgaria
Medical Center "Spectar"
🇧🇬Plovdiv, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Beijing Anding Hospital
🇨🇳Beijing, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, China
The third affiliated hospital of Sun Yat-Sen University
🇨🇳Guangzhou, China
Huzhou Third Municipal Hospital
🇨🇳Huzhou, China
Nanjing Brain Hospital
🇨🇳Nanjing, China
Shenzhen Kangning Hospital
🇨🇳Shenzhen, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Tianjin Anding Hospital
🇨🇳Tianjin, China
First Affiliated Hospital of Xi'an JiaoTong University
🇨🇳Xi'an, China
Xi'an Mental Health Center
🇨🇳Xi'an, China
Zhumadian Psychiatric Hospital
🇨🇳Zhumadian, China
National Institute of Mental Health
🇨🇿Klecany, Czechia
MP Meditrine s.r.o.
🇨🇿Ostrava, Czechia
A-SHINE s.r.o
🇨🇿Plzen, Czechia
PRAGTIS s.r.o.
🇨🇿Prague, Czechia
INEP medical s.r.o.
🇨🇿Prague, Czechia
Psychiatrie Ricany s.r.o.
🇨🇿Ricany, Czechia
Aalborg Universitetsshospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Psykiatrisk Center Glostrup
🇩🇰Glostrup, Denmark
HUS Jorvi Hospital
🇫🇮Espoo, Finland
Aurora hospital
🇫🇮Helsinki, Finland
CRST - Clinical Research Services Turku
🇫🇮Turku, Finland
Studienzentrum für Neurologie und Psychiatrie
🇩🇪Böblingen, Germany
LWL-Klinik Dortmund
🇩🇪Dortmund, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Klinikum der Universität München - Campus Innenstadt
🇩🇪München, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
JSC Romuvos Clinic
🇱🇹Kaunas, Lithuania
LUHS KH Psichiatric Clinic Mariu Division
🇱🇹Kaunas, Lithuania
JSC Medical center "Puriena"
🇱🇹Silute, Lithuania
Vilnius City Mental Health Center
🇱🇹Vilnius, Lithuania
Centro de Investigacion Integral MEDIVEST S.C
🇲🇽Chihuahua, Mexico
Centro de Investigación Clinica Acelerada, S.C.
🇲🇽Ciudad de Mexico, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
🇲🇽Culiacan, Mexico
Hospital Aranda de la Parra
🇲🇽Leon, Mexico
Iecsi S.C.
🇲🇽Monterrey, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
🇲🇽Monterrey, Mexico
BIND Investigaciones S.C.
🇲🇽San Luis Potosi, Mexico
ULS da Região de Leiria, E.P.E.
🇵🇹Leiria, Portugal
ULS de Santa Maria, E.P.E
🇵🇹Lisboa, Portugal
ULS de Loures-Odivelas, E.P.E
🇵🇹Loures, Portugal
Clinical Hospital Center Dr. Dragisa Misovic
🇷🇸Belgrade, Serbia
General Hospital Euromedik
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases Gornja Toponica
🇷🇸Gornja Toponica, Serbia
Kai-Syuan Psychiatric Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital Keelung
🇨🇳Keelung, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
NCKUH
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital(Linkou)
🇨🇳Taoyuan County, Taiwan
Taoyuan Psychiatric Center
🇨🇳Taoyuan, Taiwan
Bodmin Community Hospital
🇬🇧Bodmin, United Kingdom
The Fritchie Centre
🇬🇧Cheltenham, United Kingdom
Redesmere
🇬🇧Chester, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Maudsley Hospital
🇬🇧London, United Kingdom
Warneford Hospital
🇬🇧Oxford, United Kingdom
Moorgreen Hospital
🇬🇧Southampton, United Kingdom