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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04860830
Other study ID # 1346-0013
Secondary ID 2020-003726-23
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 18, 2021
Est. completion date January 31, 2025

Study information

Verified date March 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 586
Est. completion date January 31, 2025
Est. primary completion date January 3, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion criteria - Signed and dated written informed consent. - 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. - Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply. Exclusion criteria - Patient with current DSM-5 diagnosis other than Schizophrenia. - 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. Further exclusion criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
iclepertin
iclepertin
Placebo
Placebo

Locations

Country Name City State
Argentina Clínica Privada Banfield Banfield
Argentina Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM) Caba
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
Austria Medical University of Graz State Hospital - University Hospital Graz Graz
Austria Medical University of Innsbruck Innsbruck
Austria University Clinic Tulln Tulln An Der Donau
Austria AKH - Medical University of Vienna Vienna
Belgium CUP Vivalia -La Clairière Bertix
Belgium Sint-Kamillus Bierbeek
Belgium Universitair Psychiatrisch Centrum Duffel (UPC Duffel) Duffel
Belgium Meclinas Mechelen
Brazil Ruschel Medicina e Pesquisa Clínica Rio de Janeiro
Brazil Clínica Viver - Centro de Desospitalização Humana Sao Paulo
Bulgaria "Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry Plovdiv
Bulgaria Medical Center "Spectar" Plovdiv
Bulgaria ASMH-IPSMH - Psychiatry - Dr. Georgi Hranov Sofia
Bulgaria Medical Center Hera EOOD Sofia
Bulgaria Medical Center Intermedica Ltd. Sofia
China Beijing Anding Hospital Beijing
China The Second Xiangya Hospital Of Central South University Changsha
China 3rd Affiliated Hosp of Sun yet-sen University Guangzhou
China Huzhou Third Municipal Hospital Huzhou
China Brain Hospital Affiliated to Nanjing Med University 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
Czechia National Institute of Mental Health Klecany
Czechia MPMeditrine s.r.o. Ostrava-Poruba
Czechia A-SHINE s.r.o Plzen
Czechia INEP medical s.r.o. Prague
Czechia PRAGTIS s.r.o. Prague
Czechia Psychiatrie Ricany s.r.o. Ricany
Denmark Aalborg Universitetsshospital Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Psykiatrisk Center Glostrup Glostrup
Finland HUS Jorvi Hospital Espoo
Finland Aurora hospital Helsinki
Finland CRST - Clinical Research Services Turku Turku
Germany Synexus Clinical Research GmbH Berlin
Germany Studienzentrum für Neurologie und Psychiatrie Böblingen
Germany Pharmakologisches Studienzentrum Chemnitz GmbH Chemnitz
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
Korea, Republic of 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
Lithuania 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
Mexico 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 Hospital Universitario Dr Jose Eleuterio Gonzalez Monterrey
Mexico Iecsi S.C. Monterrey
Mexico BIND Investigaciones S.C. San Luis Potosi
Portugal 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
Serbia Clinical Hospital Center Dr. Dragisa Misovic Belgrade
Serbia General Hospital Euromedik Belgrade
Serbia University Clinical Center of Serbia Belgrade
Serbia Special Hospital for Psychiatric Diseases Gornja Toponica Gornja Toponica
Serbia Special Hospital for Psychiatric Diseases Kovin Kovin
Serbia University Clinical Center of Kragujevac Kragujevac
Taiwan 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 Tri-Service General Hospital Taipei
Taiwan Taoyuan Psychiatric Center Taoyuan
Taiwan Chang Gung Memorial Hospital(Linkou) Taoyuan County
United Kingdom 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 Beech House Maidstone
United Kingdom Warneford Hospital Oxford
United Kingdom Moorgreen Hospital Southampton
United Kingdom Foss Park Hospital York
United States Advanced Research Center, Inc. Anaheim California
United States Synexus Clinical Research Atlanta Georgia
United States Augusta University Augusta Georgia
United States Hassman Research Institute Berlin New Jersey
United States ProScience Research Group Culver City California
United States Midwest Clinical Research Dayton Ohio
United States Center for Behavioral Health, LLC Gaithersburg Maryland
United States Advanced Medical Research Group Inc Hollywood Florida
United States Ben Taub General Hospital Houston Texas
United States Sunwise Clinical Research Lafayette California
United States University of California Los Angeles Los Angeles California
United States Accel Research Sites Network Maitland Florida
United States Ivetmar Medical Group, LLC Miami Florida
United States University of Miami Miami Florida
United States Cutting Edge Research Group Oklahoma City Oklahoma
United States Rivus Wellness and Research Institute Oklahoma City Oklahoma
United States Omaha Insomnia and Psychiatric Services Omaha Nebraska
United States Nova Psychiatry Inc. Orlando Florida
United States CNRI - Los Angeles Pico Rivera California
United States UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center Raleigh North Carolina
United States Arch Clinical Trials, LLC Saint Louis Missouri
United States Stanford University Medical Center Stanford California
United States Oasis Life Care State College Pennsylvania
United States LinQ Research, LLC Sugar Land Texas

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  China,  Czechia,  Denmark,  Finland,  Germany,  Korea, Republic of,  Lithuania,  Mexico,  Portugal,  Serbia,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB) 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 After 26 weeks of treatment
Secondary Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score 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. After 26 weeks of treatment
Secondary Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Up to week 26
Secondary Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London Up to week 26
Secondary Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score 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. Up to week 24
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