New shot aims to keep depression away longer
NCT ID NCT07412756
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 6 times
Summary
This study tests whether adding a new drug called brenipatide to standard depression treatment can delay the return of major depressive symptoms. About 1000 adults with major depression who are already on stable medication will receive either brenipatide or a placebo as a shot, plus their usual care, for at least 12 months. The goal is to see if brenipatide helps people stay well longer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on a stable standard of care medication for major depressive disorder * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as * self-inject study intervention * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires Exclusion Criteria: * Have a lifetime history or current diagnosis of the following: * schizophrenia or other psychotic disorder * bipolar disorder * borderline personality disorder, or * any eating disorder. * Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma. * Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening * Are actively suicidal or deemed a significant risk for suicide * Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
179 sites in 15 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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3rd People's Hospital of Huzhou
RECRUITINGHuzhou, 313000, China
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A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
RECRUITINGValinhos, 13271-130, Brazil
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ALPHA Recherche Clinique
RECRUITINGQuébec, G3K 2P8, Canada
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ATP Clinical Research
RECRUITINGOrange, California, 92866, United States
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Abe Clinic - Arakawa
RECRUITINGArakawa City, 116-0014, Japan
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Accellacare - Moorpark
RECRUITINGMoorpark, California, 93021, United States
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Adams Clinical Boston
RECRUITINGBoston, Massachusetts, 02116, United States
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Adams Clinical Dallas
RECRUITINGDeSoto, Texas, 75115, United States
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Adams Clinical Harlem
RECRUITINGNew York, New York, 10029, United States
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Adams Clinical Watertown
RECRUITINGWatertown, Massachusetts, 02472, United States
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Aiginiteio University Hospital
NOT_YET_RECRUITINGAthens, 115 28, Greece
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Alpha Recherche Clinique
RECRUITINGQuébec, G2J 0C4, Canada
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Alpha Recherche Clinique - Lévis
RECRUITINGLévis, G6V 0C9, Canada
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Alpine Research Organization
RECRUITINGClinton, Utah, 84015, United States
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Arata Clinic
RECRUITINGNagasaki, 852-8137, Japan
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Arch Clinical Trials
RECRUITINGSt Louis, Missouri, 63141, United States
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Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
RECRUITINGTroy, Michigan, 48098, United States
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Argolida General Hospital
RECRUITINGArgos, 212 00, Greece
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Arké SMO S.A de C.V
NOT_YET_RECRUITINGVeracruz, 91900, Mexico
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Atlantic Medical
RECRUITINGPenzance, TR18 3DX, United Kingdom
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Attikon General University Hospital
RECRUITINGChaïdári, 124 62, Greece
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B&B Investigaciones Medicas S.C.
NOT_YET_RECRUITINGMazatlán, 82103, Mexico
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BR Trials - Ensaios Clinicos e Consultoria
RECRUITINGSão Paulo, 01236030, Brazil
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Barwon Health
RECRUITINGGeelong, 3220, Australia
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Beijing Anding Hospital - Affiliated Capital University of Medical Science
RECRUITINGBeijing, 100088, China
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Beijing HuiLongGuan Hospital
RECRUITINGBeijing, 100096, China
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Bluewater Clinical Research Group Inc.
NOT_YET_RECRUITINGSarnia, N7T 4X3, Canada
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CLA Research
RECRUITINGNaples, Florida, 34116, United States
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CPCLIN
NOT_YET_RECRUITINGSão Paulo, 01228-200, Brazil
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CPQuali Pesquisa Clínica
RECRUITINGSão Paulo, 01228-000, Brazil
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Cedar Valley Medical Specialists
RECRUITINGWaterloo, Iowa, 50701, United States
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CenExel iResearch, LLC
RECRUITINGDecatur, Georgia, 30030, United States
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Centre de Recherche Saint-Louis inc.
NOT_YET_RECRUITINGQuébec, G1W 4R4, Canada
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Centre for Neurology Studies
NOT_YET_RECRUITINGSurrey, V3V 0E8, Canada
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Centro de Atención Integral La Corredoria
NOT_YET_RECRUITINGOviedo, 33011, Spain
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Centro de Investigacion Clinica Chapultepec
NOT_YET_RECRUITINGMorelia, 58260, Mexico
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Centro de Pesquisa Clínica de Marília - CPCLIM
RECRUITINGMarília, 17504-072, Brazil
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Centrum Badan Klinicznych PI-House sp. z o.o.
NOT_YET_RECRUITINGGdansk, 80-546, Poland
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Centrum Medyczne Euromedis
NOT_YET_RECRUITINGSzczecin, 70-111, Poland
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Centrum Medyczne Ginemedica
NOT_YET_RECRUITINGWroclaw, 50-414, Poland
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Chang Gung Medical Foundation-Linkou Branch
RECRUITINGTaoyuan, 333, Taiwan
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Charter Research - Orlando
RECRUITINGOrlando, Florida, 32803, United States
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Cheng Hsin General Hospital
NOT_YET_RECRUITINGTaipei, 112, Taiwan
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Chonnam National University Hospital
RECRUITINGGwangju, 61469, South Korea
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Chung Shan Medical University Hospital
RECRUITINGTaichung, 402, Taiwan
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Circle Clinical Research
NOT_YET_RECRUITINGSioux Falls, South Dakota, 57104, United States
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Clerkenwell Health - London - Welbeck Street
RECRUITINGLondon, W1G 8DR, United Kingdom
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Clinhouse Centrum Medyczne
NOT_YET_RECRUITINGZabrze, 41-807, Poland
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Clinica de Investigacion en Reumatologia y Obesidad S. C.
NOT_YET_RECRUITINGGuadalajara, 44650, Mexico
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Clinilive
RECRUITINGMaringá, 87013-250, Brazil
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Complejo Asistencial de Zamora
RECRUITINGZamora, 49021, Spain
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Consano Clinical Research, LLC
RECRUITINGShavano Park, Texas, 78231, United States
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Dar Clinical Research - Ottawa
RECRUITINGOttawa, K2J 3Z6, Canada
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Devon Partnership Trust
RECRUITINGExeter, EX2 5AF, United Kingdom
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Diamond Clinic
NOT_YET_RECRUITINGKrakow, 31-559, Poland
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Diex Recherche Sherbrooke
SUSPENDEDSherbrooke, J1L 0H8, Canada
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Edinburgh Royal Infirmary
NOT_YET_RECRUITINGEdinburgh, EH16 4SA, United Kingdom
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Encore Medical Research
RECRUITINGHollywood, Florida, 33024, United States
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Facili Centro Integrado de Psiquiatria
RECRUITINGSão Bernardo do Campo, 09726-150, Brazil
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Floridian Clinical Research, LLC
RECRUITINGMiami Lakes, Florida, 33016-1518, United States
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Fujimidai Hospital
RECRUITINGHiratsuka, 259-1205, Japan
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Fukuoka University Hospital
RECRUITINGFukuoka, 814-0180, Japan
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FutureMeds GmbH
RECRUITINGBerlin, 10629, Germany
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GabiPros
NOT_YET_RECRUITINGMexico City, 07000, Mexico
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General Hospital of Tripoli Panarkadiko Evangelistria
RECRUITINGTripoli, 221 00, Greece
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Genge Partners
NOT_YET_RECRUITINGMontreal, H4A 3T2, Canada
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Guangzhou Brain Hospital
RECRUITINGGuangzhou, 510370, China
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Hefei No.4 People's Hospital
RECRUITINGHefei, 230061, China
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Heritage Medical Research Clinic
NOT_YET_RECRUITINGCalgary, T2N 4Z6, Canada
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Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
RECRUITINGTokyo, 162-0843, Japan
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Hirota Clinic
RECRUITINGKurume, 830-0033, Japan
-
Horikoshi Mental Somatic Clinic
RECRUITINGFukushima, 960-8053, Japan
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Hospital Clínic de Barcelona
RECRUITINGBarcelona, 08036, Spain
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
-
Hospital Universitario Infanta Leonor
RECRUITINGMadrid, 28031, Spain
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Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITINGSalamanca, 37005, Spain
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Hospital Universitário Onofre Lopes
RECRUITINGNatal, 59012-300, Brazil
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Hospital das Clínicas da UFMG
NOT_YET_RECRUITINGBelo Horizonte, 30130-100, Brazil
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Hospital de la Santa Creu i Sant Pau
RECRUITINGBarcelona, 08041, Spain
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ISPG - Institut für Studien zur Psychischen Gesundheit
RECRUITINGMannheim, 68165, Germany
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Indiana University Health Neuroscience Center
RECRUITINGIndianapolis, Indiana, 46202, United States
-
Institucion Hosp Hestia Palau
NOT_YET_RECRUITINGBarcelona, 08025, Spain
-
Jeju National University Hospital
RECRUITINGJeju City, 63241, South Korea
-
Jimbocho Mental Clinic
RECRUITINGChiyoda City, 101-0051, Japan
-
K2 Medical Research - Foxborough
RECRUITINGFoxborough, Massachusetts, 02035, United States
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K2 Medical Research - Maitland
RECRUITINGMaitland, Florida, 32751, United States
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K2 Medical Research - Tampa
RECRUITINGTampa, Florida, 33634, United States
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Keelung Chang Gung Memorial Hospital
RECRUITINGKeelung, 204, Taiwan
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Kelowna Health and Memory Centre
NOT_YET_RECRUITINGKelowna, V1Y 5A8, Canada
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Ketamine Clinic México
NOT_YET_RECRUITINGMexico City, 04100, Mexico
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Kishiro Mental Clinic
RECRUITINGKawasaki, 214-0014, Japan
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Kokorono Clinic Hirao
RECRUITINGFukuoka, 815-0071, Japan
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Konkuk University Medical Center
RECRUITINGSeoul, 05030, South Korea
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Korea University Ansan Hospital
RECRUITINGAnsan-si, 15355, South Korea
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Kure Medical Center
RECRUITINGKure, 737-0023, Japan
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Life Medical Research Group Corp
RECRUITINGMiami Gardens, Florida, 33014, United States
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Lyell McEwin Hospital
NOT_YET_RECRUITINGElizabeth Vale, 5112, Australia
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Maple Leaf Research
SUSPENDEDToronto, M5G 1K2, Canada
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Maynds Tower Mental Clinic
RECRUITINGShibuya-ku, 151-0053, Japan
-
Medical Care and Research SA de CV
NOT_YET_RECRUITINGMérida, 97070, Mexico
-
MentalMEDIC
NOT_YET_RECRUITINGBielsko-Biala, 43-300, Poland
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Miki Mental Clinic
RECRUITINGYokohama, 220-0023, Japan
-
Monzen-nakacho Mental Clinic
RECRUITINGKōtō City, 135-0047, Japan
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Multidisciplinary Alfred Psychiatry Research Centre
RECRUITINGMelbourne, 3004, Australia
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Multidisciplinary Mental Health Hospital of Attiki
NOT_YET_RECRUITINGAthens, 124 62, Greece
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Multidisciplinary Mental Health Hospital of Thessaloniki
NOT_YET_RECRUITINGStavroupoli, 564 29, Greece
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NZOZ Psychiatrycznej Mentis
NOT_YET_RECRUITINGLeszno, 64-100, Poland
-
Nanko Kokorono Clinic
RECRUITINGShirakawa, 961-0021, Japan
-
National Cheng Kung University Hospital
RECRUITINGTainan, 704, Taiwan
-
National Taiwan University Hospital
RECRUITINGTaipei, 10002, Taiwan
-
NeuroCentrix
RECRUITINGCarlton, 3053, Australia
-
Neurozentrum Bielefeld
RECRUITINGBielefeld, 33647, Germany
-
Northwest Clinical Research Center
RECRUITINGBellevue, Washington, 98007, United States
-
Optimal Research Sites
RECRUITINGOrange City, Florida, 32763, United States
-
Papageorgiou General Hospital of Thessaloniki
NOT_YET_RECRUITINGThessaloniki, 564 29, Greece
-
Paratus Clinical Research - Melbourne
RECRUITINGMelbourne, 3070, Australia
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Parc de Salut Mar - Hospital del Mar
RECRUITINGBarcelona, 08003, Spain
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Peking University Sixth Hospital
RECRUITINGHaidian District, 100191, China
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Penn Medicine: University of Pennsylvania Health System
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Pharmakologisches Studienzentrum Chemnitz
RECRUITINGChemnitz, 09111, Germany
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Pharmasite Research, Inc.
RECRUITINGBaltimore, Maryland, 21208, United States
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Podlaskie Centrum Psychogeriatrii
NOT_YET_RECRUITINGBialystok, 15-756, Poland
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Premier Clinical Trial Network
NOT_YET_RECRUITINGHamilton, L8L 5G4, Canada
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Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
NOT_YET_RECRUITINGPoznan, 60-192, Poland
-
Queen Elizabeth University Hospital
RECRUITINGGlasgow, G51 4TF, United Kingdom
-
Queen's Medical Centre, Nottingham University Hospitals
RECRUITINGNottingham, NG7 2UH, United Kingdom
-
Rainbow and Sea Hospital
RECRUITINGKaratsu, 847-0031, Japan
-
Re:Cognition Health
RECRUITINGFairfax, Virginia, 22031, United States
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Re:Cognition Health - Fort Worth
RECRUITINGFort Worth, Texas, 76104, United States
-
Renmin Hospital of Wuhan University
RECRUITINGWuhan, 430060, China
-
Richmond Clinical Trials
RECRUITINGRichmond, V6V 2L1, Canada
-
Ruschel Medicina e Pesquisa Clínica
RECRUITINGRio de Janeiro, 22270-060, Brazil
-
SCB Research Center
RECRUITINGBayamón, 00961, Puerto Rico
-
Sakurazaka Clinic SophyAnce
RECRUITINGTokyo, 106-0032, Japan
-
Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Sangenjaya Shinkeika Shinryonaika Clinic
RECRUITINGSetagaya City, 154-0004, Japan
-
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITINGChihuahua City, 31207, Mexico
-
Senzoku Psychosomatic Medicine Clinic
RECRUITINGMeguro-ku, 152-0012, Japan
-
Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
-
Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
-
Shandong Daizhuang Hospital
RECRUITINGJining, 272051, China
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Shanghai Mental Health Center
RECRUITINGShanghai, 200030, China
-
Shioiri Mental Clinic
RECRUITINGYokosuka, 238-0042, Japan
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Somni bene
RECRUITINGSchwerin, 19053, Germany
-
St Bartholomew's Medical Centre
RECRUITINGOxford, OX4 1XB, United Kingdom
-
Suburban Research Associates
RECRUITINGMedia, Pennsylvania, 19063, United States
-
Suizenji Life Clinic
RECRUITINGKumamoto, 862-0956, Japan
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Summit Headlands
RECRUITINGPortland, Oregon, 97210, United States
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Suzhou Guangji Hospital
RECRUITINGSuzhou, 215003, China
-
Taipei Medical University Hospital
RECRUITINGTaipei, 110, Taiwan
-
Taipei Veterans General Hospital
RECRUITINGTaipei, 11217, Taiwan
-
The Affilicated Kangning Hospital of Ningbo University
RECRUITINGNingbo, 315201, China
-
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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The First Affiliated Hospital of Nanchang University
RECRUITINGNanchang, 330000, China
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The First Hospital of Hebei Medical University
RECRUITINGShijiazhuang, 050031, China
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The Fourth People's Hospital of Chengdu
RECRUITINGChengdu, 610036, China
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The Maudsley Hospital
RECRUITINGLondon, SE5 8AZ, United Kingdom
-
The Second People's Hospital of Hunan Province
RECRUITINGChangsha, 410007, China
-
Tianjin Anding Hospital
RECRUITINGTianjin, 300022, China
-
Toowoomba Hospital
RECRUITINGToowoomba, 4350, Australia
-
Trial Tech
RECRUITINGCuritiba, 80240-280, Brazil
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Uematsu Mental Clinic
RECRUITINGChikugo, 833-0041, Japan
-
University of the Ryukyus Hospital
RECRUITINGGinowan, 901-2725, Japan
-
Universitätsklinikum Aachen
RECRUITINGAachen, 52074, Germany
-
Universitätsmedizin Johannes Gutenberg Universität Mainz
NOT_YET_RECRUITINGMainz, 55131, Germany
-
Vector Clinical Trials
RECRUITINGLas Vegas, Nevada, 89128, United States
-
Warneford Hospital
RECRUITINGOxford, OX3 7JX, United Kingdom
-
Westmead Hospital
RECRUITINGWestmead, 2145, Australia
-
Woodstock Bower Surgery
RECRUITINGRotherham, S61 1AH, United Kingdom
-
Wuxi Mental Health Center
RECRUITINGWuxi, 214151, China
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Xi An Mental Health Center
RECRUITINGXi'an, 710061, China
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Xianyang Hospital of Yan'an University
RECRUITINGXianyang, 712000, China
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Yale University School of Medicine
RECRUITINGNew Haven, Connecticut, 06519, United States
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Yamagata Sakuracho Hospital
RECRUITINGYamagata, 990-0045, Japan
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Yuge Hospital
RECRUITINGKumamoto, 861-8002, Japan
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Yutaka Clinic
RECRUITINGSagamihara, 252-0303, Japan
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ZNS Siegen
NOT_YET_RECRUITINGSiegen, 57076, Germany
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Zhumadian Psychiatric Hospital
RECRUITINGZhumadian, 463000, China
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