CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
NCT ID: NCT04860830
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
609 participants
INTERVENTIONAL
2021-08-09
2024-11-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iclepertin treatment group
BI 425809
BI 425809
Placebo group
Placebo
Placebo
Interventions
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BI 425809
BI 425809
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patients who are 18-50 years (inclusive) of age at time of consent.
* Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
\-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
* Patients should have functional impairment in day-to-day activities per investigator judgement.
* Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
* Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
* Women of childbearing potential must use highly effective methods of birth control.
Exclusion Criteria
* Cognitive impairment due to other causes, or patients with dementia or epilepsy.
* Severe movement disorders.
* Any suicidal behavior in past year or suicidal ideation in the past 3 months.
* History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
* Positive urine drug screen.
* Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
* Current participation in any investigational drug trial.
* Cognitive Remediation Therapy within 12 weeks prior to screening.
* Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
* Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
* Haemoglobin (Hb) below lower limit of normal .
* History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
* Severe renal impairment.
* Indication of liver disease.
* Any documented active or suspected malignancy or history of malignancy within 5 years.
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
18 Years
50 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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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
Sunwise Clinical Research-Walnut Creek-70166
Walnut Creek, 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
Synexus Clinical Research-Atlanta-67262
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Center for Behavioral Health, LLC
Gaithersburg, Maryland, United States
Arch Clinical Trials, LLC
St Louis, Missouri, United States
Omaha Insomnia and Psychiatric Services
Omaha, Nebraska, United States
Hassman Research Institute-Berlin-60540
Berlin, New Jersey, 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
LinQ Research, LLC-Richmond-70076
Richmond, 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)
Córdoba, , Argentina
Instituto Modelo de Neurología Lennox
Córdoba, , Argentina
Instituto Médico DAMIC S.R.L.
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
São 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
Pilsen, , Czechia
PRAGTIS s.r.o.
Prague, , Czechia
INEP medical s.r.o.
Prague, , Czechia
Psychiatrie Ricany s.r.o.
Říčany, , Czechia
Aalborg Universitetsshospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Psykiatrisk Center Glostrup
Glostrup Municipality, , 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
JSC Romuvos Clinic
Kaunas, , Lithuania
LUHS KH Psichiatric Clinic Mariu Division
Kaunas, , Lithuania
JSC Medical center "Puriena"
Šilutė, , Lithuania
Vilnius City Mental Health Center
Vilnius, , Lithuania
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, , Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, , Mexico
Hospital Aranda de la Parra
León, , Mexico
Centro de Investigación Clinica Acelerada, S.C.
Mexico City, , Mexico
Iecsi S.C.
Monterrey, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
BIND Investigaciones S.C.
San Luis Potosí City, , Mexico
ULS da Região de Leiria, E.P.E.
Leiria, , Portugal
ULS de Santa Maria, E.P.E
Lisbon, , 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
Inje University Busan Paik Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
CHA Bundang Medical Center
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Kai-Syuan Psychiatric Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Keelung
Keelung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
NCKUH
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital(Linkou)
Taoyuan, , Taiwan
Taoyuan Psychiatric Center
Taoyuan District, , 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
Countries
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Related Links
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Related Info
Other Identifiers
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2020-003726-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1346-0013
Identifier Type: -
Identifier Source: org_study_id
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