A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
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)
2 other identifiers
interventional
1,356
38 countries
300
Brief Summary
This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term. Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia. Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team. The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Mar 2022
Typical duration for phase_3 schizophrenia
300 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2025
CompletedResults Posted
Study results publicly available
April 8, 2026
CompletedApril 8, 2026
March 1, 2026
2.9 years
January 14, 2022
February 20, 2026
March 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurence of Treatment Emergent Adverse Events (TEAEs)
Number of participants with treatment emergent adverse events.
From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Secondary Outcomes (2)
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)
At baseline and at EOT. Up to a maximum of 60.1 weeks.
Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)
At baseline and at EOT. Up to a maximum of 60.1 weeks.
Study Arms (1)
Iclepertin 10 mg
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (303)
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
Clinical Innovations, Inc
Bellflower, California, 90706, United States
ProScience Research Group
Culver City, California, 90230, United States
Collaborative Neuroscience Network, LLC (CNS)
Garden Grove, California, 92845, United States
Omega Clinical Trials,LLC
La Habra, California, 90631, United States
ASCLEPES Research Centers, P.C. dba Alliance Research
Long Beach, California, 90807, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
ATP Clinical Research, Inc.
Orange, California, 92866, United States
NRC Research Institute
Orange, California, 92868, United States
CNRI - Los Angeles
Pico Rivera, California, 90660, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103, United States
Velocity Clinical Research, Santa Ana
Santa Ana, California, 92704, United States
Stanford University Medical Center
Stanford, California, 94304, United States
Collaborative Neuroscience Research
Torrance, California, 90504, United States
Institute of Living
Hartford, Connecticut, 06106, United States
Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
Advanced Medical Research Group Inc
Hollywood, Florida, 33021, United States
Accel Research Sites Network
Maitland, Florida, 32751, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33014, United States
CCM Clinical Research Group, LLC-Miami-68482
Miami, Florida, 33133, United States
Optimus U Corporation-Miami-69452
Miami, Florida, 33135, United States
University of Miami
Miami, Florida, 33136, United States
Nova Psychiatry Inc.
Orlando, Florida, 32803, United States
Synexus Clinical Research-Atlanta-67262
Atlanta, Georgia, 30328, United States
American Medical Research
Chicago, Illinois, 60612, United States
Sheppard Pratt Physicians's Practice Association, Inc.
Baltimore, Maryland, 21204, United States
Center for Behavioral Health, LLC
Gaithersburg, Maryland, 20877, United States
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
Arch Clinical Trials, LLC
St Louis, Missouri, 63141, United States
Omaha Insomnia and Psychiatric Services
Omaha, Nebraska, 68144, United States
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, 08053, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
New York State Psychiatric Institute
New York, New York, 10032, United States
Richmond Behavioral Associates-Staten Island-68636
Staten Island, New York, 10314, United States
UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
Raleigh, North Carolina, 27608, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Midwest Clinical Research
Dayton, Ohio, 45417, United States
Insight Clinical Trials, LLC, Independence
Independence, Ohio, 44131, United States
SP Research, PLLC
Oklahoma City, Oklahoma, 73112, United States
University of Oregon Prevention Science Institute
Eugene, Oregon, 97403, United States
Oasis Life Care
State College, Pennsylvania, 16801, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
Relaro Medical Trials, LLC
Dallas, Texas, 75243, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
JPS Center for Behavioral Health Recovery
Fort Worth, Texas, 76104, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
LinQ Research, LLC-Richmond-70076
Richmond, Texas, 77407, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Clínica Privada Banfield
Banfield, B1828CKR, Argentina
CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.)
CABA, 1058AAJ, Argentina
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
CABA, C1133AAH, Argentina
Fundación FunDaMos para la asistencia e investigación en psiquiatría
CABA, C1405BOA, Argentina
CEN (Centro Especializado Neurociencias)
Córdoba, 5004, Argentina
Instituto Modelo de Neurología Lennox
Córdoba, X5000FAL, Argentina
Instituto Médico DAMIC S.R.L.
Córdoba, X5003DCE, Argentina
Sanatorio Morra S.A.
Córdoba, X5009, Argentina
Instituto de Neurociencias San Agustín
La Plata, 1900, Argentina
Global Psy Asociación Civil
La Plata, CP B1904AXQ, Argentina
Resolution Psychopharmacology Research Institute
Mendoza, 5502, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, 2000, Argentina
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
Rosario, S2000QJI, Argentina
Centro Medico Luquez
San Vicente, X5006CBI, Argentina
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004, Australia
AKH - Medical University of Vienna
Vienna, 1090, Austria
CUP Vivalia -La Clairière
Bertix, 6880, Belgium
Sint-Kamillus
Bierbeek, 3360, Belgium
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
Duffel, 2570, Belgium
Meclinas
Mechelen, 2800, Belgium
CPN - Centro de Estudos em Neurociências
Belo Horizonte, 30150-270, Brazil
Hospital Sao Jose
Criciúma, 88811-000, Brazil
Trial Tech- Tecnologia em pesquisa com medicamentos
Curitiba, 80.240-280, Brazil
J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria
Goiânia, 74093-040, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09780-000, Brazil
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Cpquali Pesquisa Clinica Ltda
São Paulo, 01228-000, Brazil
BR Trials
São Paulo, 01236-030, Brazil
Clínica Viver - Centro de Desospitalização Humana
São Paulo, 04020-060, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-903, Brazil
Medical Center "Spectar"
Plovdiv, 4000, Bulgaria
Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry
Plovdiv, 4002, Bulgaria
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M5T 1R8, Canada
Biomedica Research Group
Santiago, 7500710, Chile
Psicomed Estudios Clínicos
Segunda Región, 1270244, Chile
The sixth People's Hospital of Hebei Province
Baoding, 71000, China
Beijing Anding Hospital
Beijing, 100088, China
Peking University Sixth Hospital
Beijing, 100089, China
Beijing HuiLongGuan Hospital
Beijing, 100096, China
The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province)
Changsha, 410007, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, 510370, China
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630, China
Huzhou Third Municipal Hospital
Huzhou, 313000, China
Shandong Daizhuang Hospital
Jining, 272051, China
The First Affilliated Hospital Of Kunming of Medical College
Kunming, 650032, China
Nanjing Brain Hospital
Nanjing, 210029, China
The Affilicated Kangning Hospital of Ningbo University
Ningbo, 315201, China
Shanghai Mental Health Center
Shanghai, 200030, China
Tongji Hospital, Tongji University
Shanghai, 200065, China
Shenzhen Kangning Hospital
Shenzhen, 518003, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050030, China
Tianjin Anding Hospital
Tianjin, 300222, China
Wuxi mental health center
Wuxi, 214151, China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061, China
Xi'an Mental Health Center
Xi'an, 710101, China
The Second Affiliated Hospital of Xinxiang Medical Univ.
Xinxiang, 453002, China
Zhumadian Psychiatric Hospital
Zhumadian, 463000, China
Centro de Investigación y Proyectos en neurociencia CIPNA
Barranquilla, 80020, Colombia
E.S.E Hospital Mental de Antioquia
Bello, 51053, Colombia
Instituto Colombiano del Sistema Nervioso- Clínica Montserrat
Bogotá, 110121, Colombia
Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS
Bogotá, 111166, Colombia
Psynapsis Salud Mental S.A.
Pereira, 660003, Colombia
Clincal Hospital Centre Rijeka
Rijeka, 51 000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10 000, Croatia
Solmed Polyclinic
Zagreb, 1000, Croatia
Psychiatric Hospital 'Sveti Ivan'
Zagreb, 10090, Croatia
University Psychiatric Hospital Vrapce
Zagreb, 10090, Croatia
National Institute of Mental Health
Klecany, 25067, Czechia
MP Meditrine s.r.o.
Ostrava, 70800, Czechia
A-SHINE s.r.o
Pilsen, 30100, Czechia
PRAGTIS s.r.o.
Prague, 120 00, Czechia
INEP medical s.r.o.
Prague, 18600, Czechia
Psychiatrie Ricany s.r.o.
Říčany, 251 01, Czechia
Aalborg Universitetsshospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Psykiatrisk Center Glostrup
Glostrup Municipality, 2600, Denmark
Aurora hospital
Helsinki, 00250, Finland
CRST - Clinical Research Services Turku
Turku, 20520, Finland
HOP Charles Perrens
Bordeaux, 33076, France
HOP la Colombière
Montpellier, 34295, France
HOP Hôtel-Dieu
Nantes, 44093, France
Hôpital Pasteur
Nice, 06000, France
HOP Carémeau
Nîmes, 30029, France
HOP Guillaume Régnier
Rennes, 35703, France
HOP Rouffach
Rouffach, 68250, France
HOP Nord-Saint-Priest-en-Jarez-53664
Saint-Priest-en-Jarez, 42270, France
Zentrum für klinische Forschung Dr. med. I. Schöll GmbH
Bad Homburg, 61348, Germany
Praxis Dr. Hahn, Berlin
Berlin, 13187, Germany
Studienzentrum für Neurologie und Psychiatrie
Böblingen, 71034, Germany
LWL-Klinik Dortmund
Dortmund, 44287, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Zentralinstitut für seelische Gesundheit
Mannheim, 68159, Germany
Klinikum der Universität München AÖR
München, 80336, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Studienzentrum Nord-West
Westerstede, 26655, Germany
Eginition Hospital
Athens, 11528, Greece
"Attikon" University General Hospital of Attica
Chaïdári, 12462, Greece
Psychiatric Hospital of Attica
Haidari, 12462, Greece
AX Mental Health Clinic
Heraklion, 71305, Greece
General Oncology Hospital "Agioi Anargyri"
Nea Kifissia, 14564, Greece
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57 010, Greece
Semmelweis University
Budapest, 1082, Hungary
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
A.O. Fatebenefratelli
Milan, 20121, Italy
Ist. San Raffaele Turro
Milan, 20127, Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano (TO), 10043, Italy
A.O.U. Senese
Siena, 53100, Italy
Hotei Hospital
Aichi, Konan, 483-8248, Japan
Okehazama Hospital Fujita Kokoro Care Center
Aichi, Toyoake, 470-1168, Japan
Toyota Memorial Hospital
Aichi, Toyota, 471-8513, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba, Chiba, 266-0007, Japan
Japan Institute for Health Security National Kohnodai Medical Center
Chiba, Ichikawa, 272-8516, Japan
Uematsu Mental Clinic
Fukuoka, Chikugo, 833-0041, Japan
Mental Clinic Sakurazaka
Fukuoka, Fukuoka, 810-0023, Japan
AK Clinic
Fukuoka, Fukuoka, 810-0031, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Kuramitsu Hospital
Fukuoka, Fukuoka, 819-0037, Japan
Hirota Clinic
Fukuoka, Kurume, 830-0033, Japan
Shiranui Hospital
Fukuoka, Omuta, 836-0004, Japan
Kishi Hospital
Gumma, Kiryu, 376-0011, Japan
Obihiro-Kosei General Hospital
Hokkaido, Obihiro, 080-0024, Japan
Hokudai-dori Mental Health Clinic
Hokkaido, Sapporo, 001-0010, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Tatsuta Clinic
Hyogo, Kobe, 651-0097, Japan
Kanazawa Medical University Hospital
Ishikwa, Kahoku-gun, 920-0293, Japan
Kishiro Mental Clinic
Kanagawa, Kawasaki, 214-0014, Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511, Japan
Links Mental Clinic
Kanagawa, Yokohama, 224-0001, Japan
Yokohama Onoecho Clinic
Kanagawa, Yokohama, 231-0015, Japan
Hino Hospital
Kanagawa, Yokohama, 234-0051, Japan
Yokohama City University Hospital
Kanagawa, Yokohama, 236-0004, Japan
Kochi Health Sciences Center
Kochi, Kochi, 781-8555, Japan
Yuge Neuropsychiatric Hospital
Kumamoto, Kumamoto, 861-8002, Japan
Medical Corporation Yamadakai Yatsushiro Welfare Hospital
Kumamoto, Yatsushiro, 866-0043, Japan
National Hospital Organization Maizuru Medical Center
Kyoto, Maizuru, 625-8502, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Shounan Hospital
Nagano, Matsumoto, 390-0847, Japan
Suwa Red Cross Hospital
Nagano, Suwa, 392-8510, Japan
Nara Medical University Hospital
Nara, Kashihara, 634-8522, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
University of the Ryukyus Hospital
Okinawa, Ginowan, 901-2725, Japan
Osaka City Hospital Organization Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
National Hospital Organization Hizen Psychiatric Medical Center
Saga, Kanzaki-gun, 842-0192, Japan
Rainbow and Sea Hospital
Saga, Karatsu, 847-0031, Japan
Inuo Hospital
Saga, Tosu, 841-0081, Japan
Nishi Kumagaya Hospital
Saitama, Kumagaya, 360-0816, Japan
Sho Midori Hospital
Saitama, Saitama, 336-0022, Japan
Dokkyo Medical University Hospital
Tochigi, Shimotsuga-gun, 321-0293, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Medical Corporation Seijin Hospital
Tokyo, Adachi-ku, 121-8515, Japan
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519, Japan
Nishigahara Hospital
Tokyo, Kita-ku, 114-0024, Japan
National Center of Neurology and Psychiatry
Tokyo, Kodaira, 187-8851, Japan
Asuka Hospital
Tokyo, Machida, 194-0005, Japan
Minami-Aoyama Antique Street Clinic
Tokyo, Minato-ku, 107-0062, Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541, Japan
Maynds Tower Mental Clinic
Tokyo, Shibuya-ku, 151-0053, Japan
Shinjuku East Mental Clinic
Tokyo, Shinjuku-ku, 160-0021, Japan
Ohwa Mental Clinic
Tokyo, Toshima-ku, 170-0002, Japan
Hokuriku Hospital
Toyama, Nanto, 939-1893, Japan
Yamaguchi University Hospital
Yamaguchi, Ube, 755-8505, Japan
University of Yamanashi Hospital
Yamanashi, Chuo, 409-3898, Japan
JSC Romuvos Clinic
Kaunas, LT-44279, Lithuania
LUHS KH Psichiatric Clinic Mariu Division
Kaunas, LT-53137, Lithuania
JSC Medical center "Puriena"
Šilutė, LT-99142, Lithuania
Vilnius City Mental Health Center
Vilnius, LT-10309, Lithuania
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Sentosa
Kuching, 93250, Malaysia
Hospital Tuanku Ja'afar
Seremban, 70300, Malaysia
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, 80230, Mexico
Clinica Cemelli
Guadalajara, 44660, Mexico
Hospital Aranda de la Parra
León, 37000, Mexico
Centro de Investigación Clinica Acelerada, S.C.
Mexico City, 07369, Mexico
GabiPros S.C.
Mexico City, 07810, Mexico
Instituto Nacional de Neurologia y Neurocirugia
Mexico City, 14269, Mexico
Medical Care & Research SA de CV
Mérida, 97070, Mexico
Iecsi S.C.
Monterrey, 64310, Mexico
CIT-Neuropsique S.C
Monterrey, 64610, Mexico
Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).
Monterrey, 64710, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, 64460, Mexico
BIND Investigaciones S.C.
San Luis Potosí City, 78213, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 AV, Netherlands
North Shore Hospital
Takpuna Auckland, 0622, New Zealand
Sykehuset Østfold HF, avd. Moss
Moss, N-1535, Norway
Akershus universitetssykehus Oslo
Oslo, 0963, Norway
Philippine General Hospital
Manila, Philippines, 1000, Philippines
Psychiatric Doctor's Office Ireneusz Kaczorowski
Bełchatów, 97-400, Poland
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, 15-756, Poland
Health Center Alcea
Gdansk, 80-283, Poland
MentalMEDIC
Gliwice, 44100, Poland
Central Clinical Hospital of the Medical University of Lodz
Lodz, 92-216, Poland
Individual Specialist Medical Practice Filip Rybakowski
Poznan, 60-744, Poland
EUROMEDIS Sp. z o.o., Szczecin
Szczecin, 70-111, Poland
Institute of Psychiatry and Neurology in Warsaw
Warsaw, 02-957, Poland
Clinhouse
Zabrze, 41-807, Poland
ULS da Região de Leiria, E.P.E.
Leiria, 2410-197, Portugal
Mental Health Center Sector 4
Bucharest, 040872, Romania
SC Carpe Diem SRL
Sibiu, 557260, Romania
Clinical Hospital Center Dr. Dragisa Misovic
Belgrade, 11000, Serbia
General Hospital Euromedik
Belgrade, 11000, Serbia
Institute for Mental Health
Belgrade, 11000, Serbia
Special Hospital for Psychiatric Diseases Gornja Toponica
Gornja Toponica, 18202, Serbia
Special Hospital for Psychiatric Diseases Sveti Vračevi
Novi Kneževac, 23330, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
Bojnice, 97201, Slovakia
EPAMED s.r.o.
Košice, 040 01, Slovakia
Psychiatricka Ambulancia Psycholine s.r.o.
Rimavská Sobota, 97901, Slovakia
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Chonnam National University Hospital
Gwangju, 61453, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Pusan National University Yangsan Hospital
Yangsan, 626-770, South Korea
Hestia Palau
Barcelona, 08025, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario General de Villalba
Collado de Villalba, 28400, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Puerta de Hierro
Majadahonda, 28222, Spain
Centro de Salud de San Juan
Salamanca, 37005, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Nicolás Peña
Vigo, 36211, Spain
Hospital Provincial. Complejo Asistencial de Zamora
Zamora, 49021, Spain
Psykiatriska Kliniken
Helsingborg, 20153, Sweden
Akademiska sjukhuset
Uppsala, 751 85, Sweden
Kai-Syuan Psychiatric Hospital
Kaohsiung City, 802, Taiwan
Chang Gung Memorial Hospital-Keelung
Keelung, 204, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
NCKUH
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Taoyuan Psychiatric Center
Taoyuan District, 33058, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 330, Taiwan
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Ankara University Medical School
Ankara, 06590, Turkey (Türkiye)
Istanbul University
Istanbul, 34093, Turkey (Türkiye)
Dokuz Eylul Universitesi Psikiyatri A.B.D.
Izmir, 35340, Turkey (Türkiye)
Celal Bayar Universitesi Tip Fakultesi
Manisa, 45030, Turkey (Türkiye)
Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council
Nove, 25491, Ukraine
Bodmin Community Hospital
Bodmin, PL31 2QT, United Kingdom
The Fritchie Centre
Cheltenham, GL53 9DZ, United Kingdom
Redesmere
Chester, CH2 1BQ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Maudsley Hospital
London, SE5 8AZ, United Kingdom
Warneford Hospital
Oxford, OX3 7JX, United Kingdom
Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
As per protocol, end of treatment was planned for Week 52. Forty-nine patients stayed longer on treatment (protocol deviation), up to a maximum of 60.1 weeks.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
March 21, 2022
Primary Completion
February 26, 2025
Study Completion
March 18, 2025
Last Updated
April 8, 2026
Results First Posted
April 8, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.