A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified February 2026 by Boehringer Ingelheim
Sponsor
Boehringer Ingelheim
Information Provided by (Responsible Party)
Boehringer Ingelheim
Clinicaltrials.gov Identifier
NCT05211947
Other Study ID Numbers:
1346-0014
First Submitted
January 13, 2022
First Posted
January 26, 2022
Results First Posted
February 19, 2026
Last Update Posted
April 7, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Schizophrenia
Drug: Iclepertin

Study Design

Study TypeInterventional
Actual Enrollment1356 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open Label, Single Arm, Extension Trial to Examine Long-term Safety of Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)
Study Start DateMarch 20, 2022
Actual Primary Completion DateFebruary 25, 2025
Actual Study Completion DateMarch 17, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Iclepertin 10 mg
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
Drug: Iclepertin
One 10 milligram (mg) tablet once daily.

Outcome Measures

Primary Outcome Measures
  1. Occurence of Treatment Emergent Adverse Events (TEAEs)
    Number of participants with treatment emergent adverse events.
Secondary Outcome Measures
  1. Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)
    The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as \[CGI-S EOT\] - \[CGI-S baseline\] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
  2. Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)
    Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported.

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion criteria:
Signed and dated written informed consent.
Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)).
Patients, who completed participation in the parent trial.
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
Inclusion criteria:
Signed and dated written informed consent.
Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)).
Patients, who completed participation in the parent trial.
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:
Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial since enrolment into the parent phase III trial.
Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study.
Positive urine drug screen ≥ 3 times during the treatment period of parent trial.
Patients who are currently or wish to participate in another investigational drug trial.
Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial. Further exclusion criteria apply.

Contacts and Locations

Sponsors and CollaboratorsBoehringer Ingelheim
Locations
Advanced Research Center, Inc. | Anaheim California, United States, 92805Clinical Innovations, Inc | Bellflower California, United States, 90706ProScience Research Group | Culver City California, United States, 90230Collaborative Neuroscience Network, LLC (CNS) | Garden Grove California, United States, 92845Omega Clinical Trials,LLC | La Habra California, United States, 90631ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach California, United States, 90807University of California Los Angeles | Los Angeles California, United States, 90095ATP Clinical Research, Inc. | Orange California, United States, 92866NRC Research Institute | Orange California, United States, 92868CNRI - Los Angeles | Pico Rivera California, United States, 90660Artemis Institute for Clinical Research, LLC | San Diego California, United States, 92103Velocity Clinical Research, Santa Ana | Santa Ana California, United States, 92704Stanford University Medical Center | Stanford California, United States, 94304Collaborative Neuroscience Research | Torrance California, United States, 90504Institute of Living | Hartford Connecticut, United States, 06106Connecticut Mental Health Center | New Haven Connecticut, United States, 06519Advanced Medical Research Group Inc | Hollywood Florida, United States, 33021Accel Research Sites Network | Maitland Florida, United States, 32751San Marcus Research Clinic, Inc. | Miami Florida, United States, 33014CCM Clinical Research Group, LLC-Miami-68482 | Miami Florida, United States, 33133Optimus U Corporation-Miami-69452 | Miami Florida, United States, 33135University of Miami | Miami Florida, United States, 33136Nova Psychiatry Inc. | Orlando Florida, United States, 32803Synexus Clinical Research-Atlanta-67262 | Atlanta Georgia, United States, 30328American Medical Research | Chicago Illinois, United States, 60612Sheppard Pratt Physicians's Practice Association, Inc. | Baltimore Maryland, United States, 21204Center for Behavioral Health, LLC | Gaithersburg Maryland, United States, 20877PsychCare Consultants Research | St Louis Missouri, United States, 63128Arch Clinical Trials, LLC | St Louis Missouri, United States, 63141Omaha Insomnia and Psychiatric Services | Omaha Nebraska, United States, 68144Hassman Research Institute-Marlton-66897 | Marlton New Jersey, United States, 08053Neurobehavioral Research, Inc. | Cedarhurst New York, United States, 11516New York State Psychiatric Institute | New York New York, United States, 10032Richmond Behavioral Associates-Staten Island-68636 | Staten Island New York, United States, 10314UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center | Raleigh North Carolina, United States, 27608University of Cincinnati | Cincinnati Ohio, United States, 45219Midwest Clinical Research | Dayton Ohio, United States, 45417Insight Clinical Trials, LLC, Independence | Independence Ohio, United States, 44131SP Research, PLLC | Oklahoma City Oklahoma, United States, 73112University of Oregon Prevention Science Institute | Eugene Oregon, United States, 97403Oasis Life Care | State College Pennsylvania, United States, 16801Community Clinical Research, Inc. | Austin Texas, United States, 78754Relaro Medical Trials, LLC | Dallas Texas, United States, 75243InSite Clinical Research | DeSoto Texas, United States, 75115JPS Center for Behavioral Health Recovery | Fort Worth Texas, United States, 76104North Texas Clinical Trials | Fort Worth Texas, United States, 76104Ben Taub General Hospital | Houston Texas, United States, 77030LinQ Research, LLC-Richmond-70076 | Richmond Texas, United States, 77407Northwest Clinical Research Center | Bellevue Washington, United States, 98007Clínica Privada Banfield | Banfield , Argentina, B1828CKRCENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.) | CABA , Argentina, 1058AAJFundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM) | CABA , Argentina, C1133AAHFundación FunDaMos para la asistencia e investigación en psiquiatría | CABA , Argentina, C1405BOACEN (Centro Especializado Neurociencias) | Córdoba , Argentina, 5004Instituto Modelo de Neurología Lennox | Córdoba , Argentina, X5000FALInstituto Médico DAMIC S.R.L. | Córdoba , Argentina, X5003DCESanatorio Morra S.A. | Córdoba , Argentina, X5009Instituto de Neurociencias San Agustín | La Plata , Argentina, 1900Global Psy Asociación Civil | La Plata , Argentina, CP B1904AXQResolution Psychopharmacology Research Institute | Mendoza , Argentina, 5502Instituto Médico de la Fundación Estudios Clínicos | Rosario , Argentina, 2000Centro de Investigacion y Asistencia en Psiquiatria (CIAP) | Rosario , Argentina, S2000QJICentro Medico Luquez | San Vicente , Argentina, X5006CBIMonash Alfred Psychiatry Research Centre | Melbourne Victoria, Australia, 3004AKH - Medical University of Vienna | Vienna , Austria, 1090CUP Vivalia -La Clairière | Bertix , Belgium, 6880Sint-Kamillus | Bierbeek , Belgium, 3360Universitair Psychiatrisch Centrum Duffel (UPC Duffel) | Duffel , Belgium, 2570Meclinas | Mechelen , Belgium, 2800CPN - Centro de Estudos em Neurociências | Belo Horizonte , Brazil, 30150-270Hospital Sao Jose | Criciúma , Brazil, 88811-000Trial Tech- Tecnologia em pesquisa com medicamentos | Curitiba , Brazil, 80.240-280J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria | Goiânia , Brazil, 74093-040Ruschel Medicina e Pesquisa Clínica | Rio de Janeiro , Brazil, 22270-060CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo , Brazil, 09780-000Hospital de Base - Fac Med de Sao Jose do Rio Preto | São José do Rio Preto , Brazil, 15090-000Cpquali Pesquisa Clinica Ltda | São Paulo , Brazil, 01228-000BR Trials | São Paulo , Brazil, 01236-030Clínica Viver - Centro de Desospitalização Humana | São Paulo , Brazil, 04020-060Hospital das Clinicas da Faculdade de Medicina da USP | São Paulo , Brazil, 05403-903Medical Center "Spectar" | Plovdiv , Bulgaria, 4000Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry | Plovdiv , Bulgaria, 4002University of Calgary | Calgary Alberta, Canada, T2N 4Z6Centre for Addiction and Mental Health (CAMH) | Toronto Ontario, Canada, M5T 1R8Biomedica Research Group | Santiago , Chile, 7500710Psicomed Estudios Clínicos | Segunda Región , Chile, 1270244The sixth People's Hospital of Hebei Province | Baoding , China, 71000Beijing Anding Hospital | Beijing , China, 100088Peking University Sixth Hospital | Beijing , China, 100089Beijing HuiLongGuan Hospital | Beijing , China, 100096The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province) | Changsha , China, 410007The Second Xiangya Hospital Of Central South University | Changsha , China, 410011The Affiliated Brain Hospital of Guangzhou Medical University | Guangzhou , China, 510370The third affiliated hospital of Sun Yat-Sen University | Guangzhou , China, 510630Huzhou Third Municipal Hospital | Huzhou , China, 313000Shandong Daizhuang Hospital | Jining , China, 272051The First Affilliated Hospital Of Kunming of Medical College | Kunming , China, 650032Nanjing Brain Hospital | Nanjing , China, 210029The Affilicated Kangning Hospital of Ningbo University | Ningbo , China, 315201Shanghai Mental Health Center | Shanghai , China, 200030Tongji Hospital, Tongji University | Shanghai , China, 200065Shenzhen Kangning Hospital | Shenzhen , China, 518003The First Hospital of Hebei Medical University | Shijiazhuang , China, 050030Tianjin Anding Hospital | Tianjin , China, 300222Wuxi mental health center | Wuxi , China, 214151First Affiliated Hospital of Xi'an JiaoTong University | Xi'an , China, 710061Xi'an Mental Health Center | Xi'an , China, 710101The Second Affiliated Hospital of Xinxiang Medical Univ. | Xinxiang , China, 453002Zhumadian Psychiatric Hospital | Zhumadian , China, 463000Centro de Investigación y Proyectos en neurociencia CIPNA | Barranquilla , Colombia, 80020E.S.E Hospital Mental de Antioquia | Bello , Colombia, 51053Instituto Colombiano del Sistema Nervioso- Clínica Montserrat | Bogotá , Colombia, 110121Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS | Bogotá , Colombia, 111166Psynapsis Salud Mental S.A. | Pereira , Colombia, 660003Clincal Hospital Centre Rijeka | Rijeka , Croatia, 51 000Clinical Hospital Centre Zagreb | Zagreb , Croatia, 10 000Solmed Polyclinic | Zagreb , Croatia, 1000Psychiatric Hospital 'Sveti Ivan' | Zagreb , Croatia, 10090University Psychiatric Hospital Vrapce | Zagreb , Croatia, 10090National Institute of Mental Health | Klecany , Czechia, 25067MP Meditrine s.r.o. | Ostrava , Czechia, 70800A-SHINE s.r.o | Pilsen , Czechia, 30100PRAGTIS s.r.o. | Prague , Czechia, 120 00INEP medical s.r.o. | Prague , Czechia, 18600Psychiatrie Ricany s.r.o. | Říčany , Czechia, 251 01Aalborg Universitetsshospital | Aalborg , Denmark, 9000Aarhus University Hospital | Aarhus N , Denmark, 8200Psykiatrisk Center Glostrup | Glostrup Municipality , Denmark, 2600Aurora hospital | Helsinki , Finland, 00250CRST - Clinical Research Services Turku | Turku , Finland, 20520HOP Charles Perrens | Bordeaux , France, 33076HOP la Colombière | Montpellier , France, 34295HOP Hôtel-Dieu | Nantes , France, 44093Hôpital Pasteur | Nice , France, 06000HOP Carémeau | Nîmes , France, 30029HOP Guillaume Régnier | Rennes , France, 35703HOP Rouffach | Rouffach , France, 68250HOP Nord-Saint-Priest-en-Jarez-53664 | Saint-Priest-en-Jarez , France, 42270Zentrum für klinische Forschung Dr. med. I. Schöll GmbH | Bad Homburg , Germany, 61348Praxis Dr. Hahn, Berlin | Berlin , Germany, 13187Studienzentrum für Neurologie und Psychiatrie | Böblingen , Germany, 71034LWL-Klinik Dortmund | Dortmund , Germany, 44287Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz , Germany, 55131Zentralinstitut für seelische Gesundheit | Mannheim , Germany, 68159Klinikum der Universität München AÖR | München , Germany, 80336Universitätsklinikum Tübingen | Tübingen , Germany, 72076Studienzentrum Nord-West | Westerstede , Germany, 26655Eginition Hospital | Athens , Greece, 11528"Attikon" University General Hospital of Attica | Chaïdári , Greece, 12462Psychiatric Hospital of Attica | Haidari , Greece, 12462AX Mental Health Clinic | Heraklion , Greece, 71305General Oncology Hospital "Agioi Anargyri" | Nea Kifissia , Greece, 14564University General Hospital of Thessaloniki AHEPA | Thessaloniki , Greece, 54636General Hospital of Thessaloniki "G. Papanikolaou" | Thessaloniki , Greece, 57 010Semmelweis University | Budapest , Hungary, 1082ASST degli Spedali Civili di Brescia | Brescia , Italy, 25123A.O. Fatebenefratelli | Milan , Italy, 20121Ist. San Raffaele Turro | Milan , Italy, 20127Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano (TO) , Italy, 10043A.O.U. Senese | Siena , Italy, 53100Hotei Hospital | Aichi, Konan , Japan, 483-8248Okehazama Hospital Fujita Kokoro Care Center | Aichi, Toyoake , Japan, 470-1168Toyota Memorial Hospital | Aichi, Toyota , Japan, 471-8513National Hospital Organization Shimofusa Psychiatric Medical Center | Chiba, Chiba , Japan, 266-0007Japan Institute for Health Security National Kohnodai Medical Center | Chiba, Ichikawa , Japan, 272-8516Uematsu Mental Clinic | Fukuoka, Chikugo , Japan, 833-0041Mental Clinic Sakurazaka | Fukuoka, Fukuoka , Japan, 810-0023AK Clinic | Fukuoka, Fukuoka , Japan, 810-0031Fukuoka University Hospital | Fukuoka, Fukuoka , Japan, 814-0180Kuramitsu Hospital | Fukuoka, Fukuoka , Japan, 819-0037Hirota Clinic | Fukuoka, Kurume , Japan, 830-0033Shiranui Hospital | Fukuoka, Omuta , Japan, 836-0004Kishi Hospital | Gumma, Kiryu , Japan, 376-0011Obihiro-Kosei General Hospital | Hokkaido, Obihiro , Japan, 080-0024Hokudai-dori Mental Health Clinic | Hokkaido, Sapporo , Japan, 001-0010Hokkaido University Hospital | Hokkaido, Sapporo , Japan, 060-8648Tatsuta Clinic | Hyogo, Kobe , Japan, 651-0097Kanazawa Medical University Hospital | Ishikwa, Kahoku-gun , Japan, 920-0293Kishiro Mental Clinic | Kanagawa, Kawasaki , Japan, 214-0014St. Marianna University Hospital | Kanagawa, Kawasaki , Japan, 216-8511Links Mental Clinic | Kanagawa, Yokohama , Japan, 224-0001Yokohama Onoecho Clinic | Kanagawa, Yokohama , Japan, 231-0015Hino Hospital | Kanagawa, Yokohama , Japan, 234-0051Yokohama City University Hospital | Kanagawa, Yokohama , Japan, 236-0004Kochi Health Sciences Center | Kochi, Kochi , Japan, 781-8555Yuge Neuropsychiatric Hospital | Kumamoto, Kumamoto , Japan, 861-8002Medical Corporation Yamadakai Yatsushiro Welfare Hospital | Kumamoto, Yatsushiro , Japan, 866-0043National Hospital Organization Maizuru Medical Center | Kyoto, Maizuru , Japan, 625-8502Tohoku University Hospital | Miyagi, Sendai , Japan, 980-8574Shounan Hospital | Nagano, Matsumoto , Japan, 390-0847Suwa Red Cross Hospital | Nagano, Suwa , Japan, 392-8510Nara Medical University Hospital | Nara, Kashihara , Japan, 634-8522Niigata University Medical and Dental Hospital | Niigata, Niigata , Japan, 951-8520University of the Ryukyus Hospital | Okinawa, Ginowan , Japan, 901-2725Osaka City Hospital Organization Osaka City General Hospital | Osaka, Osaka , Japan, 534-0021National Hospital Organization Hizen Psychiatric Medical Center | Saga, Kanzaki-gun , Japan, 842-0192Rainbow and Sea Hospital | Saga, Karatsu , Japan, 847-0031Inuo Hospital | Saga, Tosu , Japan, 841-0081Nishi Kumagaya Hospital | Saitama, Kumagaya , Japan, 360-0816Sho Midori Hospital | Saitama, Saitama , Japan, 336-0022Dokkyo Medical University Hospital | Tochigi, Shimotsuga-gun , Japan, 321-0293Tokushima University Hospital | Tokushima, Tokushima , Japan, 770-8503Medical Corporation Seijin Hospital | Tokyo, Adachi-ku , Japan, 121-8515Institute of Science Tokyo Hospital | Tokyo, Bunkyo-ku , Japan, 113-8519Nishigahara Hospital | Tokyo, Kita-ku , Japan, 114-0024National Center of Neurology and Psychiatry | Tokyo, Kodaira , Japan, 187-8851Asuka Hospital | Tokyo, Machida , Japan, 194-0005Minami-Aoyama Antique Street Clinic | Tokyo, Minato-ku , Japan, 107-0062Toho University Omori Medical Center | Tokyo, Ota-ku , Japan, 143-8541Maynds Tower Mental Clinic | Tokyo, Shibuya-ku , Japan, 151-0053Shinjuku East Mental Clinic | Tokyo, Shinjuku-ku , Japan, 160-0021Ohwa Mental Clinic | Tokyo, Toshima-ku , Japan, 170-0002Hokuriku Hospital | Toyama, Nanto , Japan, 939-1893Yamaguchi University Hospital | Yamaguchi, Ube , Japan, 755-8505University of Yamanashi Hospital | Yamanashi, Chuo , Japan, 409-3898JSC Romuvos Clinic | Kaunas , Lithuania, LT-44279LUHS KH Psichiatric Clinic Mariu Division | Kaunas , Lithuania, LT-53137JSC Medical center "Puriena" | Šilutė , Lithuania, LT-99142Vilnius City Mental Health Center | Vilnius , Lithuania, LT-10309Hospital Raja Permaisuri Bainun | Ipoh, Perak , Malaysia, 30450University Malaya Medical Centre | Kuala Lumpur , Malaysia, 59100Hospital Sentosa | Kuching , Malaysia, 93250Hospital Tuanku Ja'afar | Seremban , Malaysia, 70300Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. | Culiacán , Mexico, 80230Clinica Cemelli | Guadalajara , Mexico, 44660Hospital Aranda de la Parra | León , Mexico, 37000Centro de Investigación Clinica Acelerada, S.C. | Mexico City , Mexico, 07369GabiPros S.C. | Mexico City , Mexico, 07810Instituto Nacional de Neurologia y Neurocirugia | Mexico City , Mexico, 14269Medical Care & Research SA de CV | Mérida , Mexico, 97070Iecsi S.C. | Monterrey , Mexico, 64310CIT-Neuropsique S.C | Monterrey , Mexico, 64610Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME). | Monterrey , Mexico, 64710Hospital Universitario Dr Jose Eleuterio Gonzalez | Nuevo León , Mexico, 64460BIND Investigaciones S.C. | San Luis Potosí City , Mexico, 78213Universitair Medisch Centrum Groningen | Groningen , Netherlands, 9713 AVNorth Shore Hospital | Takpuna Auckland , New Zealand, 0622Sykehuset Østfold HF, avd. Moss | Moss , Norway, N-1535Akershus universitetssykehus Oslo | Oslo , Norway, 0963Philippine General Hospital | Manila, Philippines , Philippines, 1000Psychiatric Doctor's Office Ireneusz Kaczorowski | Bełchatów , Poland, 97-400Podlassian Center of Psychogeriatry, Bialystok | Bialystok , Poland, 15-756Health Center Alcea | Gdansk , Poland, 80-283MentalMEDIC | Gliwice , Poland, 44100Central Clinical Hospital of the Medical University of Lodz | Lodz , Poland, 92-216Individual Specialist Medical Practice Filip Rybakowski | Poznan , Poland, 60-744EUROMEDIS Sp. z o.o., Szczecin | Szczecin , Poland, 70-111Institute of Psychiatry and Neurology in Warsaw | Warsaw , Poland, 02-957Clinhouse | Zabrze , Poland, 41-807ULS da Região de Leiria, E.P.E. | Leiria , Portugal, 2410-197Mental Health Center Sector 4 | Bucharest , Romania, 040872SC Carpe Diem SRL | Sibiu , Romania, 557260Clinical Hospital Center Dr. Dragisa Misovic | Belgrade , Serbia, 11000General Hospital Euromedik | Belgrade , Serbia, 11000Institute for Mental Health | Belgrade , Serbia, 11000Special Hospital for Psychiatric Diseases Gornja Toponica | Gornja Toponica , Serbia, 18202Special Hospital for Psychiatric Diseases Sveti Vračevi | Novi Kneževac , Serbia, 23330Clinical Center of Vojvodina | Novi Sad , Serbia, 21000Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach | Bojnice , Slovakia, 97201EPAMED s.r.o. | Košice , Slovakia, 040 01Psychiatricka Ambulancia Psycholine s.r.o. | Rimavská Sobota , Slovakia, 97901Inje University Busan Paik Hospital | Busan , South Korea, 47392Yeungnam University Medical Center | Daegu , South Korea, 42415Daegu Catholic University Medical Center | Daegu , South Korea, 42472Chonnam National University Hospital | Gwangju , South Korea, 61453Inha University Hospital | Incheon , South Korea, 22332Seoul National University Bundang Hospital | Seongnam , South Korea, 13620Seoul National University Hospital | Seoul , South Korea, 03080Pusan National University Yangsan Hospital | Yangsan , South Korea, 626-770Hestia Palau | Barcelona , Spain, 08025Hospital Clínic de Barcelona | Barcelona , Spain, 08036Hospital Universitario General de Villalba | Collado de Villalba , Spain, 28400Hospital Universitario Reina Sofía | Córdoba , Spain, 14004Hospital Puerta de Hierro | Majadahonda , Spain, 28222Centro de Salud de San Juan | Salamanca , Spain, 37005Hospital Virgen del Rocío | Seville , Spain, 41013Hospital Clinico Universitario de Valencia | Valencia , Spain, 46010Hospital Nicolás Peña | Vigo , Spain, 36211Hospital Provincial. Complejo Asistencial de Zamora | Zamora , Spain, 49021Psykiatriska Kliniken | Helsingborg , Sweden, 20153Akademiska sjukhuset | Uppsala , Sweden, 751 85Kai-Syuan Psychiatric Hospital | Kaohsiung City , Taiwan, 802Chang Gung Memorial Hospital-Keelung | Keelung , Taiwan, 204Chung Shan Medical University Hospital | Taichung , Taiwan, 40201NCKUH | Tainan , Taiwan, 704National Taiwan University Hospital | Taipei , Taiwan, 100Taipei Veterans General Hospital | Taipei , Taiwan, 11217Taoyuan Psychiatric Center | Taoyuan , Taiwan, 33058Chang Gung Memorial Hospital, Linkou | Taoyuan , Taiwan, 330Hacettepe Universitesi Tip Fakultesi | Ankara , Turkey (Türkiye), 06230Ankara University Medical School | Ankara , Turkey (Türkiye), 06590Istanbul University | Istanbul , Turkey (Türkiye), 34093Dokuz Eylul Universitesi Psikiyatri A.B.D. | Izmir , Turkey (Türkiye), 35340Celal Bayar Universitesi Tip Fakultesi | Manisa , Turkey (Türkiye), 45030Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council | Nove , Ukraine, 25491Bodmin Community Hospital | Bodmin , United Kingdom, PL31 2QTThe Fritchie Centre | Cheltenham , United Kingdom, GL53 9DZRedesmere | Chester , United Kingdom, CH2 1BQWestern General Hospital | Edinburgh , United Kingdom, EH4 2XUQueen Elizabeth University Hospital | Glasgow , United Kingdom, G51 4TFMaudsley Hospital | London , United Kingdom, SE5 8AZWarneford Hospital | Oxford , United Kingdom, OX3 7JXMoorgreen Hospital | Southampton , United Kingdom, SO30 3JB
Study Documents (Full Text)
Documents provided by Boehringer IngelheimStudy Protocol  September 17, 2023Documents provided by Boehringer IngelheimStatistical Analysis Plan  February 17, 2025