A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Start Date
2/9/2026
Completion Date
2/1/2028
Summary
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Brenipatide
Placebo
Conditions
Locations
Accellacare - Moorpark
Moorpark, California 93021
United States
ATP Clinical Research
Orange, California 92866
United States
Yale University School of Medicine
New Haven, Connecticut 06519
United States
Encore Medical Research
Hollywood, Florida 33024
United States
K2 Medical Research - Maitland
Maitland, Florida 32751
United States
Life Medical Research Group Corp
Miami Gardens, Florida 33014
United States
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
United States
CLA Research
Naples, Florida 34116
United States
Optimal Research Sites
Orange City, Florida 32763
United States
Charter Research - Orlando
Orlando, Florida 32803
United States
K2 Medical Research - Tampa
Tampa, Florida 33634
United States
CenExel iResearch, LLC
Decatur, Georgia 30030
United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana 46202
United States
Cedar Valley Medical Specialists
Waterloo, Iowa 50701
United States
Pharmasite Research, Inc.
Baltimore, Maryland 21208
United States
Adams Clinical Boston
Boston, Massachusetts 02116
United States
K2 Medical Research - Foxborough
Foxborough, Massachusetts 02035
United States
Adams Clinical Watertown
Watertown, Massachusetts 02472
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
United States
Arch Clinical Trials
St Louis, Missouri 63141
United States
Vector Clinical Trials
Las Vegas, Nevada 89128
United States
Adams Clinical Harlem
New York, New York 10029
United States
Summit Headlands
Portland, Oregon 97210
United States
Suburban Research Associates
Media, Pennsylvania 19063
United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United States
Circle Clinical Research
Sioux Falls, South Dakota 57104
United States
Adams Clinical Dallas
DeSoto, Texas 75115
United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104
United States
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United States
Alpine Research Organization
Clinton, Utah 84015
United States
Re:Cognition Health
Fairfax, Virginia 22031
United States
Northwest Clinical Research Center
Bellevue, Washington 98007
United States
NeuroCentrix
Carlton, 3053
Australia
Lyell McEwin Hospital
Elizabeth Vale, 5112
Australia
Barwon Health
Geelong, 3220
Australia
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, 3004
Australia
Paratus Clinical Research - Melbourne
Melbourne, 3070
Australia
Toowoomba Hospital
Toowoomba, 4350
Australia
Westmead Hospital
Westmead, 2145
Australia
Hospital das Clínicas da UFMG
Belo Horizonte, 30130-100
Brazil
Trial Tech
Curitiba, 80240-280
Brazil
Clinilive
Maringá, 87013-250
Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
Brazil
Hospital Universitário Onofre Lopes
Natal, 59012-300
Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
Brazil
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150
Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Brazil
CPCLIN
São Paulo, 01228-200
Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030
Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, 13271-130
Brazil
Heritage Medical Research Clinic
Calgary, T2N 4Z6
Canada
Premier Clinical Trial Network
Hamilton, L8L 5G4
Canada
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Canada
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9
Canada
Genge Partners
Montreal, H4A 3T2
Canada
Dar Clinical Research - Ottawa
Ottawa, K2J 3Z6
Canada
Centre de Recherche Saint-Louis inc.
Québec, G1W 4R4
Canada
Alpha Recherche Clinique
Québec, G2J 0C4
Canada
ALPHA Recherche Clinique
Québec, G3K 2P8
Canada
Richmond Clinical Trials
Richmond, V6V 2L1
Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
Canada
Diex Recherche Sherbrooke
Sherbrooke, J1L 0H8
Canada
Centre for Neurology Studies
Surrey, V3V 0E8
Canada
Maple Leaf Research
Toronto, M5G 1K2
Canada
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
China
Beijing HuiLongGuan Hospital
Beijing, 100096
China
The Second People's Hospital of Hunan Province
Changsha, 410007
China
The Fourth People's Hospital of Chengdu
Chengdu, 610036
China
Guangzhou Brain Hospital
Guangzhou, 510370
China
Peking University Sixth Hospital
Haidian District, 100191
China
Hefei No.4 People's Hospital
Hefei, 230061
China
3rd People's Hospital of Huzhou
Huzhou, 313000
China
Shandong Daizhuang Hospital
Jining, 272051
China
The First Affiliated Hospital of Nanchang University
Nanchang, 330000
China
The Affilicated Kangning Hospital of Ningbo University
Ningbo, 315201
China
Shanghai Mental Health Center
Shanghai, 200030
China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
China
Suzhou Guangji Hospital
Suzhou, 215003
China
Tianjin Anding Hospital
Tianjin, 300022
China
Renmin Hospital of Wuhan University
Wuhan, 430060
China
Wuxi Mental Health Center
Wuxi, 214151
China
Xi An Mental Health Center
Xi'an, 710061
China
Xianyang Hospital of Yan'an University
Xianyang, 712000
China
Zhumadian Psychiatric Hospital
Zhumadian, 463000
China
Universitätsklinikum Aachen
Aachen, 52074
Germany
FutureMeds GmbH
Berlin, 10629
Germany
Neurozentrum Bielefeld
Bielefeld, 33647
Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131
Germany
ISPG - Institut für Studien zur Psychischen Gesundheit
Mannheim, 68165
Germany
Somni bene
Schwerin, 19053
Germany
ZNS Siegen
Siegen, 57076
Germany
Argolida General Hospital
Argos, 212 00
Greece
Aiginiteio University Hospital
Athens, 115 28
Greece
Multidisciplinary Mental Health Hospital of Attiki
Athens, 124 62
Greece
Attikon General University Hospital
Chaïdári, 124 62
Greece
Multidisciplinary Mental Health Hospital of Thessaloniki
Stavroupoli, 564 29
Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 564 29
Greece
General Hospital of Tripoli Panarkadiko Evangelistria
Tripoli, 221 00
Greece
Abe Clinic - Arakawa
Arakawa City, 116-0014
Japan
Uematsu Mental Clinic
Chikugo, 833-0041
Japan
Jimbocho Mental Clinic
Chiyoda City, 101-0051
Japan
Fukuoka University Hospital
Fukuoka, 814-0180
Japan
Kokorono Clinic Hirao
Fukuoka, 815-0071
Japan
Horikoshi Mental Somatic Clinic
Fukushima, 960-8053
Japan
University of the Ryukyus Hospital
Ginowan, 901-2725
Japan
Fujimidai Hospital
Hiratsuka, 259-1205
Japan
Rainbow and Sea Hospital
Karatsu, 847-0031
Japan
Kishiro Mental Clinic
Kawasaki, 214-0014
Japan
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047
Japan
Yuge Hospital
Kumamoto, 861-8002
Japan
Suizenji Life Clinic
Kumamoto, 862-0956
Japan
Kure Medical Center
Kure, 737-0023
Japan
Hirota Clinic
Kurume, 830-0033
Japan
Senzoku Psychosomatic Medicine Clinic
Meguro-ku, 152-0012
Japan
Arata Clinic
Nagasaki, 852-8137
Japan
Yutaka Clinic
Sagamihara, 252-0303
Japan
Sangenjaya Shinkeika Shinryonaika Clinic
Setagaya City, 154-0004
Japan
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
Japan
Nanko Kokorono Clinic
Shirakawa, 961-0021
Japan
Sakurazaka Clinic SophyAnce
Tokyo, 106-0032
Japan
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, 162-0843
Japan
Yamagata Sakuracho Hospital
Yamagata, 990-0045
Japan
Miki Mental Clinic
Yokohama, 220-0023
Japan
Shioiri Mental Clinic
Yokosuka, 238-0042
Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
Mexico
B&B Investigaciones Medicas S.C.
Mazatlán, 82103
Mexico
Ketamine Clinic México
Mexico City, 04100
Mexico
GabiPros
Mexico City, 07000
Mexico
Medical Care and Research SA de CV
Mérida, 97070
Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260
Mexico
Arké SMO S.A de C.V
Veracruz, 91900
Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
Poland
MentalMEDIC
Bielsko-Biala, 43-300
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Poland
Diamond Clinic
Krakow, 31-559
Poland
NZOZ Psychiatrycznej Mentis
Leszno, 64-100
Poland
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, 60-192
Poland
Centrum Medyczne Euromedis
Szczecin, 70-111
Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798
Poland
Centrum Medyczne Ginemedica
Wroclaw, 50-414
Poland
Clinhouse Centrum Medyczne
Zabrze, 41-807
Poland
SCB Research Center
Bayamón, 00961
Puerto Rico
Korea University Ansan Hospital
Ansan-si, 15355
South Korea
Chonnam National University Hospital
Gwangju, 61469
South Korea
Jeju National University Hospital
Jeju City, 63241
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Konkuk University Medical Center
Seoul, 05030
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
South Korea
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Spain
Institucion Hosp Hestia Palau
Barcelona, 08025
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Clínic de Barcelona
Barcelona, 08036
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain
Centro de Atención Integral La Corredoria
Oviedo, 33011
Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37005
Spain
Complejo Asistencial de Zamora
Zamora, 49021
Spain
Keelung Chang Gung Memorial Hospital
Keelung, 204
Taiwan
Chung Shan Medical University Hospital
Taichung, 402
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Taipei Medical University Hospital
Taipei, 110
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Cheng Hsin General Hospital
Taipei, 112
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
United Kingdom
Devon Partnership Trust
Exeter, EX2 5AF
United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF
United Kingdom
The Maudsley Hospital
London, SE5 8AZ
United Kingdom
Clerkenwell Health - London - Welbeck Street
London, W1G 8DR
United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, NG7 2UH
United Kingdom
Warneford Hospital
Oxford, OX3 7JX
United Kingdom
St Bartholomew's Medical Centre
Oxford, OX4 1XB
United Kingdom
Atlantic Medical
Penzance, TR18 3DX
United Kingdom
Woodstock Bower Surgery
Rotherham, S61 1AH
United Kingdom