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

An 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)

ClinicalTrials.gov processed this data on November 18, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified November 2024 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 14, 2022
First Posted: January 27, 2022
Last Update Posted: November 19, 2024
Last Verified: November 2024
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Schizophrenia	Drug: BI 425809

Study Design

Study Type	Interventional
Anticipated Enrollment	1401 participants
Design Allocation	N/A
Interventional Model	Single Group Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	An 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 Date	March 21, 2022
Anticipated Primary Completion Date	December 18, 2025
Anticipated Study Completion Date	December 18, 2025

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Patients with cognitive impairment due to schizophrenia	Drug: BI 425809 BI 425809

Outcome Measures

Primary Outcome Measures

Occurrence of treatment emergent adverse events (TEAEs) [up to 1 year and 12 days]

Secondary Outcome Measures

Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT) [up to 1 year]
The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S is rated ordinal from 1 to 7, with 1=normal (not at all ill) to 7=patient among the most extremely ill patients.
Change from baseline in Haemoglobin (Hb) to EOT [up to 1 year]

Eligibility Criteria

Ages Eligible for Study	18 Years to 51 Years (Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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 Collaborators	Boehringer Ingelheim
Locations	Advanced Research Center, Inc. \| Anaheim, California, United States, 92805 Clinical Innovations, Inc \| Bellflower, California, United States, 90706 ATP Clinical Research, Inc. \| Costa Mesa, California, United States, 92626 ProScience Research Group \| Culver City, California, United States, 90230 Collaborative Neuroscience Network, LLC (CNS) \| Garden Grove, California, United States, 92845 Omega Clinical Trials,LLC \| La Habra, California, United States, 90631 ASCLEPES Research Centers, P.C. dba Alliance Research \| Long Beach, California, United States, 90807 University of California Los Angeles \| Los Angeles, California, United States, 90095 University of California Los Angeles \| Los Angeles, California, United States, 90095 NRC Research Institute \| Orange, California, United States, 92868 CNRI - Los Angeles \| Pico Rivera, California, United States, 90660 Artemis Institute for Clinical Research, LLC \| San Diego, California, United States, 92103 Velocity Clinical Research-Santa Ana-68902 \| Santa Ana, California, United States, 92704 Stanford University Medical Center \| Stanford, California, United States, 94304 Collaborative Neuroscience Research \| Torrance, California, United States, 90504 Institute of Living \| Hartford, Connecticut, United States, 06106 Connecticut Mental Health Center \| New Haven, Connecticut, United States, 06519 Advanced Medical Research Group Inc \| Hollywood, Florida, United States, 33021 Accel Research Sites Network \| Maitland, Florida, United States, 32751 San Marcus Research Clinic, Inc. \| Miami, Florida, United States, 33014 CCM Clinical Research Group, LLC-Miami-68482 \| Miami, Florida, United States, 33133 Optimus U Corporation-Miami-69452 \| Miami, Florida, United States, 33135 University of Miami \| Miami, Florida, United States, 33136 Nova Psychiatry Inc. \| Orlando, Florida, United States, 32803 Synexus Clinical Research-Atlanta-67262 \| Atlanta, Georgia, United States, 30328 American Medical Research \| Chicago, Illinois, United States, 60612 Center for Behavioral Health, LLC \| Gaithersburg, Maryland, United States, 20877 PsychCare Consultants Research \| Saint Louis, Missouri, United States, 63128 Arch Clinical Trials, LLC \| Saint Louis, Missouri, United States, 63141 Omaha Insomnia and Psychiatric Services \| Omaha, Nebraska, United States, 68144 Hassman Research Institute-Berlin-60540 \| Berlin, New Jersey, United States, 08009 Neurobehavioral Research, Inc. \| Cedarhurst, New York, United States, 11516 New York State Psychiatric Institute \| New York, New York, United States, 10032 Richmond Behavioral Associates-Staten Island-68636 \| Staten Island, New York, United States, 10314 UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center \| Raleigh, North Carolina, United States, 27608 Insight Clinical Trials \| Beachwood, Ohio, United States, 44122 University of Cincinnati \| Cincinnati, Ohio, United States, 45219 Midwest Clinical Research \| Dayton, Ohio, United States, 45417 SP Research, PLLC \| Oklahoma City, Oklahoma, United States, 73112 University of Oregon Prevention Science Institute \| Eugene, Oregon, United States, 97403 Community Clinical Research, Inc. \| Austin, Texas, United States, 78754 Relaro Medical Trials, LLC \| Dallas, Texas, United States, 75243 InSite Clinical Research \| DeSoto, Texas, United States, 75115 JPS Center for Behavioral Health Recovery \| Fort Worth, Texas, United States, 76104 North Texas Clinical Trials \| Fort Worth, Texas, United States, 76104 Ben Taub General Hospital \| Houston, Texas, United States, 77030 LinQ Research, LLC-Richmond-70076 \| Richmond, Texas, United States, 77407 Northwest Clinical Research Center \| Bellevue, Washington, United States, 98007 Clínica Privada Banfield \| Banfield, Argentina, B1828CKR CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.) \| Caba, Argentina, 1058AAJ Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM) \| Caba, Argentina, C1133AAH Fundación FunDaMos para la asistencia e investigación en psiquiatría \| Caba, Argentina, C1405BOA CEN (Centro Especializado Neurociencias) \| Cordoba, Argentina, 5004 Instituto Médico DAMIC S.R.L. \| Cordoba, Argentina, X5003DCE Instituto Modelo de Neurología Lennox \| Córdoba, Argentina, X5000FAL Sanatorio Morra S.A. \| Córdoba, Argentina, X5009 Instituto de Neurociencias San Agustín \| La Plata, Argentina, 1900 Global Psy Asociación Civil \| La Plata, Argentina, CP B1904AXQ Resolution Psychopharmacology Research Institute \| Mendoza, Argentina, 5502 Instituto Médico de la Fundación Estudios Clínicos \| Rosario, Argentina, 2000 Centro de Investigacion y Asistencia en Psiquiatria (CIAP) \| Rosario, Argentina, S2000QJI Centro Medico Luquez \| San Vicente, Argentina, X5006CBI Monash Alfred Psychiatry Research Centre \| Melbourne, Victoria, Australia, 3004 AKH - Medical University of Vienna \| Vienna, Austria, 1090 CUP Vivalia -La Clairière \| Bertix, Belgium, 6880 Sint-Kamillus \| Bierbeek, Belgium, 3360 Universitair Psychiatrisch Centrum Duffel (UPC Duffel) \| Duffel, Belgium, 2570 Meclinas \| Mechelen, Belgium, 2800 CPN - Centro de Estudos em Neurociências \| Belo Horizonte, Brazil, 30150-270 Hospital Sao Jose \| Criciuma, Brazil, 88811-000 Trial Tech- Tecnologia em pesquisa com medicamentos \| Curitiba, Brazil, 80.240-280 J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria \| Goiania, Brazil, 74093-040 Ruschel Medicina e Pesquisa Clínica \| Rio de Janeiro, Brazil, 22270-060 Hospital de Base - Fac Med de Sao Jose do Rio Preto \| Sao Jose do Rio Preto, Brazil, 15090-000 BR Trials \| Sao Paulo, Brazil, 01236-030 Clínica Viver - Centro de Desospitalização Humana \| Sao Paulo, Brazil, 04020-060 CEMEC - Centro Multidisciplinar de Estudos Clínicos \| São Bernardo do Campo, Brazil, 09780-000 Cpquali Pesquisa Clinica Ltda \| São Paulo, Brazil, 01228-000 Hospital das Clinicas da FMUSP \| São Paulo, Brazil, 05403-903 Medical Center "Spectar" \| Plovdiv, Bulgaria, 4000 Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry \| Plovdiv, Bulgaria, 4002 University of Calgary \| Calgary, Alberta, Canada, T2N 4Z6 Centre for Addiction and Mental Health (CAMH) \| Toronto, Ontario, Canada, M5T 1R8 Biomedica Research Group \| Santiago, Chile, 7500710 Psicomed Estudios Clínicos \| Segunda Región, Chile, 1270244 The sixth People's Hospital of Hebei Province \| Baoding, China, 71000 Beijing Anding Hospital \| Beijing, China, 100088 Peking University Sixth Hospital \| Beijing, China, 100089 Beijing HuiLongGuan Hospital \| Beijing, China, 100096 Brain hospital of Hunan province \| Changsha, China, 410007 The Second Xiangya Hospital Of Central South University \| Changsha, China, 410011 The Affiliated Brain Hospital of Guangzhou Medical University \| Guangzhou, China, 510370 The third affiliated hospital of Sun Yat-Sen University \| Guangzhou, China, 510630 Huzhou Third Municipal Hospital \| Huzhou, China, 313000 Shandong Daizhuang Hospital \| Jining, China, 272051 The First Affilliated Hospital Of Kunming of Medical College \| Kunming, China, 650032 Nanjing Brain Hospital \| Nanjing, China, 210029 The Affilicated Kangning Hospital of Ningbo University \| Ningbo, China, 315201 Shanghai Mental Health Center \| Shanghai, China, 200030 Tongji Hospital, Tongji University \| Shanghai, China, 200065 Shenzhen Kangning Hospital \| Shenzhen, China, 518003 The First Hospital of Hebei Medical University \| Shijiazhuang, China, 050030 Tianjin Anding Hospital \| Tianjin, China, 300222 Wuxi mental health center \| Wuxi, China, 214151 First Affiliated Hospital of Xi'an JiaoTong University \| Xi'an, China, 710061 Xi'an Mental Health Center \| Xi'an, China, 710101 The Second Affiliated Hospital of Xinxiang Medical Univ. \| Xinxiang, China, 453002 Zhumadian Psychiatric Hospital \| Zhumadian, China, 463000 Centro de Investigación y Proyectos en neurociencia CIPNA \| Barranquilla, Colombia, 80020 E.S.E Hospital Mental de Antioquia \| Bello, Colombia, 51053 Instituto Colombiano del Sistema Nervioso- Clínica Montserrat \| Bogota, Colombia, 110121 Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS \| Bogotá, Colombia, 111166 Psynapsis Salud Mental S.A. \| Pereira, Colombia, 660003 Clincal Hospital Centre Rijeka \| Rijeka, Croatia, 51 000 Clinical Hospital Centre Zagreb \| Zagreb, Croatia, 10 000 Solmed Polyclinic \| Zagreb, Croatia, 1000 Psychiatric Hospital 'Sveti Ivan' \| Zagreb, Croatia, 10090 University Psychiatric Hospital Vrapce \| Zagreb, Croatia, 10090 National Institute of Mental Health \| Klecany, Czechia, 25067 MP Meditrine s.r.o. \| Ostrava, Czechia, 70800 A-SHINE s.r.o \| Plzen, Czechia, 30100 PRAGTIS s.r.o. \| Prague, Czechia, 120 00 INEP medical s.r.o. \| Prague, Czechia, 18600 Psychiatrie Ricany s.r.o. \| Ricany, Czechia, 251 01 Aalborg Universitetsshospital \| Aalborg, Denmark, 9000 Aarhus University Hospital \| Aarhus N, Denmark, 8200 Psykiatrisk Center Glostrup \| Glostrup, Denmark, 2600 Aurora hospital \| Helsinki, Finland, 00250 CRST - Clinical Research Services Turku \| Turku, Finland, 20520 HOP Charles Perrens \| Bordeaux, France, 33076 HOP la Colombière \| Montpellier, France, 34295 HOP Hôtel-Dieu \| Nantes, France, 44093 HOP Pasteur \| Nice, France, 06000 HOP Carémeau \| Nîmes, France, 30029 HOP Rouffach \| Rouffach, France, 68250 HOP Nord-Saint-Priest-en-Jarez-53664 \| Saint Priest en Jarez, France, 42270 Zentrum für klinische Forschung Dr. med. I. Schöll GmbH \| Bad Homburg, Germany, 61348 Praxis Dr. Hahn, Berlin \| Berlin, Germany, 13187 Studienzentrum für Neurologie und Psychiatrie \| Böblingen, Germany, 71034 LWL-Klinik Dortmund \| Dortmund, Germany, 44287 Universitätsmedizin der Johannes Gutenberg-Universität Mainz \| Mainz, Germany, 55131 Zentralinstitut für seelische Gesundheit \| Mannheim, Germany, 68159 Klinikum der Universität München AÖR \| München, Germany, 80336 Studienzentrum Nord-West \| Westerstede, Germany, 26655 Eginition Hospital \| Athens, Greece, 11528 "Attikon" University General Hospital of Attica \| Chaidari, Greece, 12462 Psychiatric Hospital of Attica \| Haidari, Greece, 12462 AX Mental Health Clinic \| Heraclion, Greece, 71305 General Oncology Hospital "Agioi Anargyri" \| Nea Kifisia, Greece, 14564 University General Hospital of Thessaloniki AHEPA \| Thessaloniki, Greece, 54636 General Hospital of Thessaloniki "G. Papanikolaou" \| Thessaloniki, Greece, 57 010 ASST degli Spedali Civili di Brescia \| Brescia, Italy, 25123 A.O. Fatebenefratelli \| Milano, Italy, 20121 Ist. San Raffaele Turro \| Milano, Italy, 20127 Azienda Sanitaria Ospedale S. Luigi Gonzaga \| Orbassano (to), Italy, 10043 A.O.U. Senese Policlinico Santa Maria alle Scotte \| Siena, Italy, 53100 Hotei Hospital \| Aichi, Konan, Japan, 483-8248 Okehazama Hospital Fujita Kokoro Care Center \| Aichi, Toyoake, Japan, 470-1168 Toyota Memorial Hospital \| Aichi, Toyota, Japan, 471-8513 National Hospital Organization Shimofusa Psychiatric Medical Center \| Chiba, Chiba, Japan, 266-0007 National Center for Global Health and Medicine Kohnodai Hospital \| Chiba, Ichikawa, Japan, 272-8516 Uematsu Mental Clinic \| Fukuoka, Chikugo, Japan, 833-0041 Mental Clinic Sakurazaka \| Fukuoka, Fukuoka, Japan, 810-0023 AK Clinic \| Fukuoka, Fukuoka, Japan, 810-0031 Fukuoka University Hospital \| Fukuoka, Fukuoka, Japan, 814-0180 Kuramitsu Hospital \| Fukuoka, Fukuoka, Japan, 819-0037 Hirota Clinic \| Fukuoka, Kurume, Japan, 830-0033 Shiranui Hospital \| Fukuoka, Omuta, Japan, 836-0004 Kishi Hospital \| Gumma, Kiryu, Japan, 376-0011 Obihiro-Kosei General Hospital \| Hokkaido, Obihiro, Japan, 080-0024 Hokudai-dori Mental Health Clinic \| Hokkaido, Sapporo, Japan, 001-0010 Hokkaido University Hospital \| Hokkaido, Sapporo, Japan, 060-8648 Tatsuta Clinic \| Hyogo, Kobe, Japan, 651-0097 Kanazawa Medical University Hospital \| Ishikwa, Kahoku-gun, Japan, 920-0293 Kishiro Mental Clinic \| Kanagawa, Kawasaki, Japan, 214-0014 St. Marianna University Hospital \| Kanagawa, Kawasaki, Japan, 216-8511 Links Mental Clinic \| Kanagawa, Yokohama, Japan, 224-0001 Yokohama Onoecho Clinic \| Kanagawa, Yokohama, Japan, 231-0015 Hino Hospital \| Kanagawa, Yokohama, Japan, 234-0051 Yokohama City University Hospital \| Kanagawa, Yokohama, Japan, 236-0004 Kochi Health Sciences Center \| Kochi, Kochi, Japan, 781-8555 Yuge Neuropsychiatric Hospital \| Kumamoto, Kumamoto, Japan, 861-8002 Medical Corporation Yamadakai Yatsushiro Welfare Hospital \| Kumamoto, Yatsushiro, Japan, 866-0043 National Hospital Organization Maizuru Medical Center \| Kyoto, Maizuru, Japan, 625-8502 Tohoku University Hospital \| Miyagi, Sendai, Japan, 980-8574 Shounan Hospital \| Nagano, Matsumoto, Japan, 390-0847 Suwa Red Cross Hospital \| Nagano, Suwa, Japan, 392-8510 Nara Medical University Hospital \| Nara, Kashihara, Japan, 634-8522 Niigata University Medical and Dental Hospital \| Niigata, Niigata, Japan, 951-8520 Osaka City Hospital Organization Osaka City General Hospital \| Osaka, Osaka, Japan, 534-0021 National Hospital Organization Hizen Psychiatric Medical Center \| Saga, Kanzaki-gun, Japan, 842-0192 Rainbow and Sea Hospital \| Saga, Karatsu, Japan, 847-0031 Inuo Hospital \| Saga, Tosu, Japan, 841-0081 Nishi Kumagaya Hospital \| Saitama, Kumagaya, Japan, 360-0816 Sho Midori Hospital \| Saitama, Saitama, Japan, 336-0022 Dokkyo Medical University Hospital \| Tochigi, Shimotsuga-gun, Japan, 321-0293 Tokushima University Hospital \| Tokushima, Tokushima, Japan, 770-8503 Medical Corporation Seijin Hospital \| Tokyo, Adachi-ku, Japan, 121-8515 Institute of Science Tokyo Hospital \| Tokyo, Bunkyo-ku, Japan, 113-8519 Nishigahara Hospital \| Tokyo, Kita-ku, Japan, 114-0024 National Center of Neurology and Psychiatry \| Tokyo, Kodaira, Japan, 187-8851 Asuka Hospital \| Tokyo, Machida, Japan, 194-0005 Minami-Aoyama Antique Street Clinic \| Tokyo, Minato-ku, Japan, 107-0062 Maynds Tower Mental Clinic \| Tokyo, Shibuya-ku, Japan, 151-0053 Shinjuku East Mental Clinic \| Tokyo, Shinjuku-ku, Japan, 160-0022 Ohwa Mental Clinic \| Tokyo, Toshima-ku, Japan, 170-0002 Hokuriku Hospital \| Toyama, Nanto, Japan, 939-1893 Yamaguchi University Hospital \| Yamaguchi, Ube, Japan, 755-8505 University of Yamanashi Hospital \| Yamanashi, Chuo, Japan, 409-3898 Inje University Busan Paik Hospital \| Busan, Korea, Republic of, 47392 Yeungnam University Medical Center \| Daegu, Korea, Republic of, 42415 Daegu Catholic University Medical Center \| Daegu, Korea, Republic of, 42472 Chonnam National University Hospital \| Gwangju, Korea, Republic of, 61453 Seoul National University Bundang Hospital \| Gyeonggi-Do, Korea, Republic of, 13620 Inha University Hospital \| Incheon, Korea, Republic of, 22332 Seoul National University Hospital \| Seoul, Korea, Republic of, 03080 Pusan National University Yangsan Hospital \| Yangsan, Korea, Republic of, 626-770 JSC Romuvos Clinic \| Kaunas, Lithuania, LT-44279 LUHS KH Psichiatric Clinic Mariu Division \| Kaunas, Lithuania, LT-53137 JSC Medical center "Puriena" \| Silute, Lithuania, LT-99142 Vilnius City Mental Health Center \| Vilnius, Lithuania, LT-10309 Hospital Raja Permaisuri Bainun \| Ipoh, Perak, Malaysia, 30450 University of Malaya Medical Centre \| Kuala Lumpur, Malaysia, 59100 Hospital Sentosa \| Kuching, Malaysia, 93250 Hospital Tuanku Ja'afar \| Seremban, Malaysia, 70300 GabiPros S.C. \| Cdmx, Mexico, 07810 Centro de Investigación Clinica Acelerada, S.C. \| Ciudad de Mexico, Mexico, 07369 Instituto Nacional de Neurologia y Neurocirugia \| Ciudad de Mexico, Mexico, 14269 Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. \| Culiacan, Mexico, 80230 Clinica Cemelli \| Guadalajara, Mexico, 44660 Hospital Aranda de la Parra \| Leon, Mexico, 37000 Medical Care & Research SA de CV \| Merida, Mexico, 97070 Iecsi S.C. \| Monterrey, Mexico, 64310 CIT-Neuropsique S.C \| Monterrey, Mexico, 64610 Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME). \| Monterrey, Mexico, 64710 Hospital Universitario Dr Jose Eleuterio Gonzalez \| Nuevo León, Mexico, 64460 BIND Investigaciones S.C. \| San Luis Potosi, Mexico, 78213 Universitair Medisch Centrum Groningen \| Groningen, Netherlands, 9713 AV North Shore Hospital, Takapuna \| Takpuna Auckland, New Zealand, 0622 Sykehuset Østfold HF, avd. Moss \| Moss, Norway, N-1535 Akershus universitetssykehus Oslo \| Oslo, Norway, 0963 Philippine General Hospital \| Manila, Philippines, Philippines, 1000 Psychiatric Doctor's Office Ireneusz Kaczorowski \| Bełchatow, Poland, 97-400 Podlassian Center of Psychogeriatry, Bialystok \| Bialystok, Poland, 15-756 Health Center Alcea \| Gdansk, Poland, 80-283 MentalMEDIC \| Gliwice, Poland, 44100 Central Teaching Hospital of the Medical University of Lodz \| Lodz, Poland, 92-216 Individual Specialist Medical Practice Filip Rybakowski \| Poznan, Poland, 60-744 Institute of Psychiatry and Neurology in Warsaw \| Warsaw, Poland, 02-957 Clinhouse \| Zabrze, Poland, 41-807 Mental Health Center Sector 4 \| Bucharest, Romania, 040872 SC Carpe Diem SRL \| Sibiu, Romania, 557260 Clinical Hospital Center Dr. Dragisa Misovic \| Belgrade, Serbia, 11000 General Hospital Euromedik \| Belgrade, Serbia, 11000 Institute for Mental Health \| Belgrade, Serbia, 11000 Special Hospital for Psychiatric Diseases Gornja Toponica \| Gornja Toponica, Serbia, 18202 Special Hospital for Psychiatric Diseases Sveti Vračevi \| Novi Knezevac, Serbia, 23330 Clinical Center of Vojvodina \| Novi Sad, Serbia, 21000 Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach \| Bojnice, Slovakia, 97201 EPAMED s.r.o. \| Kosice, Slovakia, 040 01 Psychiatricka Ambulancia Psycholine s.r.o. \| Rimavska Sobota, Slovakia, 97901 Hestia Palau \| Barcelona, Spain, 08025 Hospital Universitario Reina Sofía-Córdoba-40500 \| Córdoba, Spain, 14004 Hospital Puerta de Hierro \| Majadahonda, Spain, 28222 Centro de Salud de San Juan \| Salamanca, Spain, 37005 Hospital Virgen del Rocío \| Sevilla, Spain, 41013 Hospital Clínico de Valencia \| Valencia, Spain, 46010 Hospital Nicolás Peña \| Vigo, Spain, 36211 Hospital Provincial. Complejo Asistencial de Zamora \| Zamora, Spain, 49021 Psykiatriska Kliniken \| Helsingborg, Sweden, 20153 Akademiska sjukhuset \| Uppsala, Sweden, 751 85 Kai-Syuan Psychiatric Hospital \| Kaohsiung, Taiwan, 802 Chang Gung Memorial Hospital Keelung \| Keelung, Taiwan, 20401 Chung Shan Medical University Hospital \| Taichung, Taiwan, 40201 NCKUH \| Tainan, Taiwan, 704 National Taiwan University Hospital \| Taipei, Taiwan, 100 Taipei Veterans General Hospital \| Taipei, Taiwan, 11217 Taoyuan Psychiatric Center \| Taoyuan, Taiwan, 33058 Chang Gung Memorial Hospital(Linkou) \| Taoyuan, Taiwan, 330 Hacettepe Universitesi Tip Fakultesi \| Ankara, Turkey, 06230 Ankara University Medical School \| Ankara, Turkey, 06590 Istanbul University \| Istanbul, Turkey, 34093 Dokuz Eylul Universitesi Psikiyatri A.B.D. \| Izmir, Turkey, 35340 Celal Bayar Universitesi Tip Fakultesi \| Manisa, Turkey, 45030 Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council \| Nove, Ukraine, 25491 Bodmin Community Hospital \| Bodmin, United Kingdom, PL31 2QT The Fritchie Centre \| Cheltenham, United Kingdom, GL53 9DZ Redesmere \| Chester, United Kingdom, CH2 1BQ Western General Hospital \| Edinburgh, United Kingdom, EH4 2XU Queen Elizabeth University Hospital \| Glasgow, United Kingdom, G51 4TF Maudsley Hospital \| London, United Kingdom, SE5 8AZ Warneford Hospital \| Oxford, United Kingdom, OX3 7JX Moorgreen Hospital \| Southampton, United Kingdom, SO30 3JB