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

Last updated: April 17, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Terminated

Phase

3

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

Iclepertin

BI 425809

Clinical Study ID

NCT05211947
1346-0014
2020-003745-11
  • Ages 18-51
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Signed and dated written informed consent.

  • Clinically stable outpatients who have been diagnosed with schizophrenia (as perDiagnostic 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. Furtherinclusion criteria apply.

Exclusion

Exclusion criteria:

  • Participant who developed DSM-5 diagnosis other than Schizophrenia or any conditionthat would prevent the patient from participating in the extension trial sinceenrolment into the parent phase III trial.

  • Any suicidal behavior and/or suicidal ideation of type 5 based on the ColumbiaSuicidality Severity Rating Scale (C-SSRS) in parent trial and up to and includingVisit 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 drugtrial.

  • Any clinically significant finding or condition in the judgment of the investigatorthat would jeopardize the patient´s safety while participating in the trial or theircapability to participate in the trial.

Further exclusion criteria apply.

Study Design

Total Participants: 1362
Treatment Group(s): 2
Primary Treatment: Iclepertin
Phase: 3
Study Start date:
March 21, 2022
Estimated Completion Date:
March 13, 2025

Connect with a study center

  • Clínica Privada Banfield

    Banfield, B1828CKR
    Argentina

    Site Not Available

  • CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.)

    Caba, 1058AAJ
    Argentina

    Site Not Available

  • CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.)

    Caba, 1058AAJ
    Argentina

    Active - Recruiting

  • Fundación FunDaMos para la asistencia e investigación en psiquiatría

    Caba, C1405BOA
    Argentina

    Site Not Available

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

    Caba, C1133AAH
    Argentina

    Site Not Available

  • CEN (Centro Especializado Neurociencias)

    Cordoba, 5004
    Argentina

    Site Not Available

  • Instituto Médico DAMIC S.R.L.

    Cordoba, X5003DCE
    Argentina

    Site Not Available

  • Instituto Modelo de Neurología Lennox

    Córdoba, X5000FAL
    Argentina

    Site Not Available

  • Sanatorio Morra S.A.

    Córdoba, X5009
    Argentina

    Site Not Available

  • Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata, 1900
    Argentina

    Active - Recruiting

  • Global Psy Asociación Civil

    La Plata, CP B1904AXQ
    Argentina

    Site Not Available

  • Instituto de Neurociencias San Agustín

    La Plata, 1900
    Argentina

    Site Not Available

  • Resolution Psychopharmacology Research Institute

    Mendoza, 5502
    Argentina

    Site Not Available

  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

    Rosario, S2000QJI
    Argentina

    Site Not Available

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, 2000
    Argentina

    Site Not Available

  • Centro Medico Luquez

    San Vicente, X5006CBI
    Argentina

    Site Not Available

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • AKH - Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • CUP Vivalia -La Clairière

    Bertix, 6880
    Belgium

    Site Not Available

  • Sint-Kamillus

    Bierbeek, 3360
    Belgium

    Site Not Available

  • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

    Duffel, 2570
    Belgium

    Site Not Available

  • Meclinas

    Mechelen, 2800
    Belgium

    Site Not Available

  • CPN - Centro de Estudos em Neurociências

    Belo Horizonte, 30150-270
    Brazil

    Site Not Available

  • Hospital Sao Jose

    Criciuma, 88811-000
    Brazil

    Site Not Available

  • Trial Tech- Tecnologia em pesquisa com medicamentos

    Curitiba, 80.240-280
    Brazil

    Site Not Available

  • J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria

    Goiania, 74093-040
    Brazil

    Site Not Available

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060
    Brazil

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  • Hospital de Base - Fac Med de Sao Jose do Rio Preto

    Sao Jose do Rio Preto, 15090-000
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    Sao Jose do Rio Preto, 15090-000
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    Sao Paulo, 01236-030
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    Sao Paulo, 04020-060
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    São Bernardo do Campo, 09780-000
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    São Paulo, 01228-000
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    São Paulo, 05403-903
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  • Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry

    Plovdiv, 4002
    Bulgaria

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    Plovdiv, 4002
    Bulgaria

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    Toronto, Ontario M5T 1R8
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    Guangzhou, 510630
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    Active - Recruiting

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    Guangzhou, 510630
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    Guiyang, 550000
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    Huzhou, 313000
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    Jining, 272051
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    Shanghai, 200030
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    Shanghai, 200065
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    Shenzhen, 518003
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    Xinxiang, 453002
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  • Centro de Investigación y Proyectos en neurociencia CIPNA

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    Colombia

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  • Instituto Colombiano del Sistema Nervioso- Clínica Montserrat

    Bogota, 110121
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  • Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS

    Bogotá, 111166
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  • Psynapsis Salud Mental S.A.

    Pereira, 660003
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  • Clincal Hospital Centre Rijeka

    Rijeka, 51 000
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    Zagreb, 10 000
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    Zagreb, 10090
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    Zagreb, 1000
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    Ostrava, 70800
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  • MP Meditrine s.r.o.

    Ostrava, 70800
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    Plzen, 30100
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    Prague, 18600
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    Prague, 120 00
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    Ricany, 251 01
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  • Aalborg Universitetsshospital

    Aalborg, 9000
    Denmark

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  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

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    Aarhus N, 8200
    Denmark

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  • Psykiatrisk Center Glostrup

    Glostrup, 2600
    Denmark

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  • Aurora hospital

    Helsinki, 00250
    Finland

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    Turku, 20520
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    Bordeaux, 33076
    France

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    Montpellier, 34295
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    Nantes, 44093
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    Nice, 06000
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    Nîmes, 30029
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    Rennes, 35703
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    Rouffach, 68250
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    Saint Priest en Jarez, 42270
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    Saint Priest en Jarez, 42270
    France

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    Bad Homburg, 61348
    Germany

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    Bad Homburg, 61350
    Germany

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  • Zentrum für klinische Forschung Dr. med. I. Schöll GmbH

    Bad Homburg, 61348
    Germany

    Site Not Available

  • Praxis Dr. Hahn, Berlin

    Berlin, 13187
    Germany

    Site Not Available

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen, 71034
    Germany

    Site Not Available

  • LWL-Klinik Dortmund

    Dortmund, 44287
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159
    Germany

    Site Not Available

  • Klinikum der Universität München - Campus Innenstadt

    München, 80336
    Germany

    Active - Recruiting

  • Klinikum der Universität München AÖR

    München, 80336
    Germany

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    Tübingen, 72076
    Germany

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  • Studienzentrum Nord-West

    Westerstede, 26655
    Germany

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  • Eginition Hospital

    Athens, 11528
    Greece

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  • "Attikon" University General Hospital of Attica

    Chaidari, 12462
    Greece

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    Haidari, 12462
    Greece

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  • AX Mental Health Clinic

    Heraclion, 71305
    Greece

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  • General Oncology Hospital "Agioi Anargyri"

    Nea Kifisia, 14564
    Greece

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  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57 010
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    Thessaloniki, 54636
    Greece

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    Budapest, 1082
    Hungary

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  • ASST degli Spedali Civili di Brescia

    Brescia, 25123
    Italy

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    Milano, 20121
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    Orbassano (to), 10043
    Italy

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  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100
    Italy

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  • Hotei Hospital

    Aichi, Konan, 483-8248
    Japan

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    Aichi, Toyoake, 470-1168
    Japan

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  • Toyota Memorial Hospital

    Aichi, Toyota, 471-8513
    Japan

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  • National Hospital Organization Shimofusa Psychiatric Medical Center

    Chiba, Chiba, 266-0007
    Japan

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  • National Center for Global Health and Medicine Kohnodai Hospital

    Chiba, Ichikawa, 272-8516
    Japan

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  • Uematsu Mental Clinic

    Fukuoka, Chikugo, 833-0041
    Japan

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  • AK Clinic

    Fukuoka, Fukuoka, 810-0031
    Japan

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  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180
    Japan

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  • Kuramitsu Hospital

    Fukuoka, Fukuoka, 819-0037
    Japan

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  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka, 810-0023
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    Fukuoka, Kurume, 830-0033
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    Fukuoka, Omuta, 836-0004
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    Gumma, Kiryu, 376-0011
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    Hokkaido, Obihiro, 080-0024
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    Hokkaido, Sapporo, 060-8648
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    Hokkaido, Sapporo, 001-0010
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    Hyogo, Kobe, 651-0097
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    Ishikwa, Kahoku-gun, 920-0293
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    Kanagawa, Kawasaki, 214-0014
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    Kanagawa, Kawasaki, 216-8511
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    Kanagawa, Yokohama, 234-0051
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    Kanagawa, Yokohama, 224-0001
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    Kanagawa, Yokohama, 236-0004
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    Kanagawa, Yokohama, 231-0015
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    Kochi, Kochi, 781-8555
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    Kumamoto, Kumamoto, 861-8002
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    Kumamoto, Yatsushiro, 866-0043
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    Kyoto, Maizuru, 625-8502
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    Miyagi, Sendai, 980-8574
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    Mexico

    Site Not Available

  • BIND Investigaciones S.C.

    San Luis Potosi, 78213
    Mexico

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 AV
    Netherlands

    Site Not Available

  • North Shore Hospital

    Takpuna Auckland, 0622
    New Zealand

    Site Not Available

  • North Shore Hospital, Takapuna

    Takpuna Auckland, 0622
    New Zealand

    Site Not Available

  • Sykehuset Østfold HF, avd. Moss

    Moss, N-1535
    Norway

    Site Not Available

  • Akershus universitetssykehus Oslo

    Oslo, 0963
    Norway

    Site Not Available

  • Philippine General Hospital

    Manila, Philippines, 1000
    Philippines

    Site Not Available

  • Psychiatric Doctor's Office Ireneusz Kaczorowski

    Bełchatow, 97-400
    Poland

    Site Not Available

  • Podlassian Center of Psychogeriatry, Bialystok

    Bialystok, 15-756
    Poland

    Site Not Available

  • Health Center Alcea

    Gdansk, 80-283
    Poland

    Site Not Available

  • MentalMEDIC

    Gliwice, 44100
    Poland

    Site Not Available

  • Central Teaching Hospital of the Medical University of Lodz

    Lodz, 92-216
    Poland

    Site Not Available

  • Individual Specialist Medical Practice Filip Rybakowski

    Poznan, 60-744
    Poland

    Site Not Available

  • EUROMEDIS Sp. z o.o., Szczecin

    Szczecin, 70-111
    Poland

    Site Not Available

  • Institute of Psychiatry and Neurology in Warsaw

    Warsaw, 02-957
    Poland

    Site Not Available

  • Clinhouse

    Zabrze, 41-807
    Poland

    Site Not Available

  • ULS da Região de Leiria, E.P.E.

    Leiria, 2410-197
    Portugal

    Site Not Available

  • Mental Health Center Sector 4

    Bucharest, 040872
    Romania

    Site Not Available

  • SC Carpe Diem SRL

    Sibiu, 557260
    Romania

    Site Not Available

  • Clinical Hospital Center Dr. Dragisa Misovic

    Belgrade, 11000
    Serbia

    Site Not Available

  • General Hospital Euromedik

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute for Mental Health

    Belgrade, 11000
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases Gornja Toponica

    Gornja Toponica, 18202
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases Sveti Vračevi

    Novi Knezevac, 23330
    Serbia

    Site Not Available

  • Clinical Center of Vojvodina

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

    Bojnice, 97201
    Slovakia

    Site Not Available

  • EPAMED s.r.o.

    Kosice, 040 01
    Slovakia

    Site Not Available

  • Psychiatricka Ambulancia Psycholine s.r.o.

    Rimavska Sobota, 97901
    Slovakia

    Site Not Available

  • Hestia Palau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario General de Villalba

    Collado De Villalba, 28400
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía-Córdoba-40500

    Córdoba, 14004
    Spain

    Site Not Available

  • Centro de Salud mental de Getafe

    Getafe, 28903
    Spain

    Site Not Available

  • Hospital Puerta de Hierro

    Majadahonda, 28222
    Spain

    Site Not Available

  • Centro de Salud de San Juan

    Salamanca, 37005
    Spain

    Site Not Available

  • Hospital Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Nicolás Peña

    Vigo, 36211
    Spain

    Site Not Available

  • Hospital Provincial. Complejo Asistencial de Zamora

    Zamora, 49021
    Spain

    Site Not Available

  • Psykiatriska Kliniken

    Helsingborg, 20153
    Sweden

    Site Not Available

  • Akademiska sjukhuset

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Kai-Syuan Psychiatric Hospital

    Kaohsiung, 802
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital Keelung

    Keelung, 20401
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Site Not Available

  • NCKUH

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital(Linkou)

    Taoyuan, 330
    Taiwan

    Site Not Available

  • Taoyuan Psychiatric Center

    Taoyuan, 33058
    Taiwan

    Site Not Available

  • Ankara University Medical School

    Ankara, 06590
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230
    Turkey

    Site Not Available

  • Istanbul University

    Istanbul, 34093
    Turkey

    Site Not Available

  • Dokuz Eylul Universitesi Psikiyatri A.B.D.

    Izmir, 35340
    Turkey

    Site Not Available

  • Celal Bayar Universitesi Tip Fakultesi

    Manisa, 45030
    Turkey

    Site Not Available

  • Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council

    Nove, 25491
    Ukraine

    Site Not Available

  • Bodmin Community Hospital

    Bodmin, PL31 2QT
    United Kingdom

    Site Not Available

  • The Fritchie Centre

    Cheltenham, GL53 9DZ
    United Kingdom

    Site Not Available

  • Redesmere

    Chester, CH2 1BQ
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Maudsley Hospital

    London, SE5 8AZ
    United Kingdom

    Site Not Available

  • Warneford Hospital

    Oxford, OX3 7JX
    United Kingdom

    Site Not Available

  • Moorgreen Hospital

    Southampton, SO30 3JB
    United Kingdom

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • Clinical Innovations, Inc

    Bellflower, California 90706
    United States

    Site Not Available

  • ATP Clinical Research, Inc.

    Costa Mesa, California 92626
    United States

    Site Not Available

  • ProScience Research Group

    Culver City, California 90230
    United States

    Site Not Available

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California 92845
    United States

    Site Not Available

  • Omega Clinical Trials,LLC

    La Habra, California 90631
    United States

    Site Not Available

  • ASCLEPES Research Centers, P.C. dba Alliance Research

    Long Beach, California 90807
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • ATP Clinical Research, Inc.

    Orange, California 92866
    United States

    Site Not Available

  • NRC Research Institute

    Orange, California 92868
    United States

    Site Not Available

  • CNRI - Los Angeles

    Pico Rivera, California 90660
    United States

    Site Not Available

  • Artemis Institute for Clinical Research, LLC

    San Diego, California 92103
    United States

    Site Not Available

  • Velocity Clinical Research

    Santa Ana, California 92704
    United States

    Completed

  • Velocity Clinical Research-Santa Ana-68902

    Santa Ana, California 92704
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94304
    United States

    Site Not Available

  • Collaborative Neuroscience Research

    Torrance, California 90504
    United States

    Site Not Available

  • Institute of Living

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Connecticut Mental Health Center

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Advanced Medical Research Group Inc

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Accel Research Sites Network

    Maitland, Florida 32751
    United States

    Site Not Available

  • CCM Clinical Research Group, LLC

    Miami, Florida 33133
    United States

    Site Not Available

  • CCM Clinical Research Group, LLC-Miami-68482

    Miami, Florida 33133
    United States

    Site Not Available

  • Optimus U Corporation

    Miami, Florida 33135
    United States

    Site Not Available

  • Optimus U Corporation-Miami-69452

    Miami, Florida 33135
    United States

    Site Not Available

  • San Marcus Research Clinic, Inc.

    Miami, Florida 33014
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Nova Psychiatry Inc.

    Orlando, Florida 32803
    United States

    Site Not Available

  • Synexus Clinical Research

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Synexus Clinical Research-Atlanta-67262

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • American Medical Research

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Sheppard Pratt Physicians's Practice Association, Inc.

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • Center for Behavioral Health, LLC

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Arch Clinical Trials, LLC

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Omaha Insomnia and Psychiatric Services

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Hassman Research Institute-Berlin-60540

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Hassman Research Institute-Marlton-66897

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • New York State Psychiatric Institute

    New York, New York 10032
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10314
    United States

    Active - Recruiting

  • Richmond Behavioral Associates-Staten Island-68636

    Staten Island, New York 10314
    United States

    Site Not Available

  • UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center

    Raleigh, North Carolina 27608
    United States

    Site Not Available

  • Insight Clinical Trials

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Midwest Clinical Research

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Insight Clinical Trials, LLC, Independence

    Independence, Ohio 44131
    United States

    Site Not Available

  • Rivus Wellness and Research Institute

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • SP Research, PLLC

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • University of Oregon Prevention Science Institute

    Eugene, Oregon 97403
    United States

    Site Not Available

  • Oasis Life Care

    State College, Pennsylvania 16801
    United States

    Site Not Available

  • Community Clinical Research, Inc.

    Austin, Texas 78754
    United States

    Site Not Available

  • Relaro Medical Trials, LLC

    Dallas, Texas 75243
    United States

    Site Not Available

  • InSite Clinical Research

    DeSoto, Texas 75115
    United States

    Site Not Available

  • JPS Center for Behavioral Health Recovery

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • North Texas Clinical Trials

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Ben Taub General Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • LinQ Research, LLC

    Richmond, Texas 77407
    United States

    Site Not Available

  • LinQ Research, LLC-Richmond-70076

    Richmond, Texas 77407
    United States

    Site Not Available

  • LinQ Research, LLC

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

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