Major Depression Clinical Trials

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A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Status: Recruiting
Location: See all (186) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Accellacare - Moorpark
NOT_YET_RECRUITING
Moorpark
ATP Clinical Research
RECRUITING
Orange
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Florida
Encore Medical Research
NOT_YET_RECRUITING
Hollywood
K2 Medical Research - Maitland
NOT_YET_RECRUITING
Maitland
Life Medical Research Group Corp
RECRUITING
Miami Gardens
Floridian Clinical Research, LLC
NOT_YET_RECRUITING
Miami Lakes
CLA Research
NOT_YET_RECRUITING
Naples
Optimal Research Sites
RECRUITING
Orange City
Charter Research - Orlando
RECRUITING
Orlando
K2 Medical Research - Tampa
NOT_YET_RECRUITING
Tampa
Georgia
CenExel iResearch, LLC
RECRUITING
Decatur
Iowa
Cedar Valley Medical Specialists
NOT_YET_RECRUITING
Waterloo
Indiana
Indiana University Health Neuroscience Center
RECRUITING
Indianapolis
Massachusetts
Adams Clinical Boston
RECRUITING
Boston
Adams Clinical Watertown
RECRUITING
Watertown
Maryland
Pharmasite Research, Inc.
RECRUITING
Baltimore
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
NOT_YET_RECRUITING
Troy
Missouri
Arch Clinical Trials
NOT_YET_RECRUITING
St Louis
Nevada
Vector Clinical Trials
RECRUITING
Las Vegas
New York
Adams Clinical Harlem
RECRUITING
New York
Oregon
Summit Headlands
NOT_YET_RECRUITING
Portland
Pennsylvania
Suburban Research Associates
RECRUITING
Media
Penn Medicine: University of Pennsylvania Health System
NOT_YET_RECRUITING
Philadelphia
Rhode Island
K2 Medical Research - East Providence
NOT_YET_RECRUITING
East Providence
South Dakota
Circle Clinical Research
NOT_YET_RECRUITING
Sioux Falls
Texas
Adams Clinical Dallas
RECRUITING
Desoto
Re:Cognition Health - Fort Worth
RECRUITING
Fort Worth
Consano Clinical Research, LLC
NOT_YET_RECRUITING
Shavano Park
Utah
Alpine Research Organization
RECRUITING
Clinton
Virginia
Re:Cognition Health
NOT_YET_RECRUITING
Fairfax
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Australia
Mater Misericordiae Limited
NOT_YET_RECRUITING
Brisbane
NeuroCentrix
NOT_YET_RECRUITING
Carlton
Lyell McEwin Hospital
NOT_YET_RECRUITING
Elizabeth Vale
Barwon Health
NOT_YET_RECRUITING
Geelong
Multidisciplinary Alfred Psychiatry Research Centre
NOT_YET_RECRUITING
Melbourne
Paratus Clinical Research - Melbourne
NOT_YET_RECRUITING
Melbourne
Mildura Base Hospital
NOT_YET_RECRUITING
Mildura
Toowoomba Hospital
NOT_YET_RECRUITING
Toowoomba
Innovate Clinical Research
NOT_YET_RECRUITING
Waitara
Westmead Hospital
NOT_YET_RECRUITING
Westmead
Brazil
Hospital das Clínicas da UFMG
NOT_YET_RECRUITING
Belo Horizonte
Trial Tech
NOT_YET_RECRUITING
Curitiba
Centro de Pesquisa Clínica de Marília - CPCLIM
NOT_YET_RECRUITING
Marília
Clinilive
NOT_YET_RECRUITING
Maringá
Hospital Universitário Onofre Lopes
NOT_YET_RECRUITING
Natal
Ruschel Medicina e Pesquisa Clínica
NOT_YET_RECRUITING
Rio De Janeiro
Facili Centro Integrado de Psiquiatria
NOT_YET_RECRUITING
São Bernardo Do Campo
BR Trials - Ensaios Clinicos e Consultoria
NOT_YET_RECRUITING
São Paulo
CPCLIN
NOT_YET_RECRUITING
São Paulo
CPQuali Pesquisa Clínica
NOT_YET_RECRUITING
São Paulo
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
NOT_YET_RECRUITING
Valinhos
Canada
Heritage Medical Research Clinic
NOT_YET_RECRUITING
Calgary
Premier Clinical Trial Network
NOT_YET_RECRUITING
Hamilton
Winterberry Research Inc.
NOT_YET_RECRUITING
Hamilton
Alpha Recherche Clinique - Lévis
NOT_YET_RECRUITING
Lévis
Genge Partners
NOT_YET_RECRUITING
Montreal
Dar Clinical Research - Ottawa
NOT_YET_RECRUITING
Ottawa
Alpha Recherche Clinique
NOT_YET_RECRUITING
Québec
ALPHA Recherche Clinique
NOT_YET_RECRUITING
Québec
Centre de Recherche Saint-Louis inc.
NOT_YET_RECRUITING
Québec
Richmond Clinical Trials
NOT_YET_RECRUITING
Richmond
Bluewater Clinical Research Group Inc.
NOT_YET_RECRUITING
Sarnia
Diex Recherche Sherbrooke
NOT_YET_RECRUITING
Sherbrooke
Centre for Neurology Studies
NOT_YET_RECRUITING
Surrey
Maple Leaf Research
NOT_YET_RECRUITING
Toronto
China
Beijing Anding Hospital - Affiliated Capital University of Medical Science
NOT_YET_RECRUITING
Beijing
Beijing HuiLongGuan Hospital
NOT_YET_RECRUITING
Beijing
The Second People's Hospital of Hunan Province
NOT_YET_RECRUITING
Changsha
The Fourth People's Hospital of Chengdu
NOT_YET_RECRUITING
Chengdu
Guangzhou Brain Hospital
NOT_YET_RECRUITING
Guangzhou
Peking University Sixth Hospital
NOT_YET_RECRUITING
Haidian District
Hefei No.4 People's Hospital
NOT_YET_RECRUITING
Hefei
3rd People's Hospital of Huzhou
NOT_YET_RECRUITING
Huzhou
Shandong Daizhuang Hospital
NOT_YET_RECRUITING
Jining
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Affilicated Kangning Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Shanghai Mental Health Center
NOT_YET_RECRUITING
Shanghai
The First Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Suzhou Guangji Hospital
NOT_YET_RECRUITING
Suzhou
Tianjin Anding Hospital
NOT_YET_RECRUITING
Tianjin
Renmin Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Wuxi Mental Health Center
NOT_YET_RECRUITING
Wuxi
Xi An Mental Health Center
NOT_YET_RECRUITING
Xi'an
Xianyang Hospital of Yan'an University
NOT_YET_RECRUITING
Xianyang
Zhumadian Psychiatric Hospital
NOT_YET_RECRUITING
Zhumadian
Germany
Universitätsklinikum Aachen
NOT_YET_RECRUITING
Aachen
FutureMeds GmbH
NOT_YET_RECRUITING
Berlin
Neurozentrum Bielefeld
NOT_YET_RECRUITING
Bielefeld
Pharmakologisches Studienzentrum Chemnitz
NOT_YET_RECRUITING
Chemnitz
Universitätsmedizin Johannes Gutenberg Universität Mainz
NOT_YET_RECRUITING
Mainz
ISPG - Institut für Studien zur Psychischen Gesundheit
NOT_YET_RECRUITING
Mannheim
Somni bene
NOT_YET_RECRUITING
Schwerin
ZNS Siegen
NOT_YET_RECRUITING
Siegen
Greece
Argolida General Hospital
NOT_YET_RECRUITING
Argos
Aiginiteio University Hospital
NOT_YET_RECRUITING
Athens
Multidisciplinary Mental Health Hospital of Attiki
NOT_YET_RECRUITING
Athens
Attikon General University Hospital
NOT_YET_RECRUITING
Chaïdári
Multidisciplinary Mental Health Hospital of Thessaloniki
NOT_YET_RECRUITING
Stavroupoli
Papageorgiou General Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
General Hospital of Tripoli Panarkadiko Evangelistria
NOT_YET_RECRUITING
Tripoli
Japan
Abe Clinic - Arakawa
NOT_YET_RECRUITING
Arakawa City
Uematsu Mental Clinic
NOT_YET_RECRUITING
Chikugo
Jimbocho Mental Clinic
NOT_YET_RECRUITING
Chiyoda City
Fukuoka University Hospital
NOT_YET_RECRUITING
Fukuoka
Kokorono Clinic Hirao
NOT_YET_RECRUITING
Fukuoka
Horikoshi Mental Somatic Clinic
NOT_YET_RECRUITING
Fukushima
University of the Ryukyus Hospital
NOT_YET_RECRUITING
Ginowan
Fujimidai Hospital
NOT_YET_RECRUITING
Hiratsuka
Rainbow and Sea Hospital
NOT_YET_RECRUITING
Karatsu
Kishiro Mental Clinic
NOT_YET_RECRUITING
Kawasaki
Monzen-nakacho Mental Clinic
NOT_YET_RECRUITING
Kōtō City
Suizenji Life Clinic
NOT_YET_RECRUITING
Kumamoto
Yuge Hospital
NOT_YET_RECRUITING
Kumamoto
Kure Medical Center
NOT_YET_RECRUITING
Kure
Hirota Clinic
NOT_YET_RECRUITING
Kurume
Senzoku Psychosomatic Medicine Clinic
NOT_YET_RECRUITING
Meguro-ku
Arata Clinic
NOT_YET_RECRUITING
Nagasaki
Yutaka Clinic
NOT_YET_RECRUITING
Sagamihara
Sangenjaya Shinkeika Shinryonaika Clinic
NOT_YET_RECRUITING
Setagaya City
Maynds Tower Mental Clinic
NOT_YET_RECRUITING
Shibuya-ku
Nanko Kokorono Clinic
NOT_YET_RECRUITING
Shirakawa
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
NOT_YET_RECRUITING
Tokyo
Sakurazaka Clinic SophyAnce
NOT_YET_RECRUITING
Tokyo
Yamagata Sakuracho Hospital
NOT_YET_RECRUITING
Yamagata
Miki Mental Clinic
NOT_YET_RECRUITING
Yokohama
Shioiri Mental Clinic
NOT_YET_RECRUITING
Yokosuka
Mexico
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITING
Chihuahua City
Clinica de Investigacion en Reumatologia y Obesidad S. C.
NOT_YET_RECRUITING
Guadalajara
B&B Investigaciones Medicas S.C.
NOT_YET_RECRUITING
Mazatlán
Medical Care and Research SA de CV
NOT_YET_RECRUITING
Mérida
GabiPros
NOT_YET_RECRUITING
Mexico City
Ketamine Clinic México
NOT_YET_RECRUITING
Mexico City
Centro de Investigacion Clinica Chapultepec
NOT_YET_RECRUITING
Morelia
Arké SMO S.A de C.V
NOT_YET_RECRUITING
Veracruz
Instituto Jalisciense de Salud Mental
NOT_YET_RECRUITING
Zapopan
Poland
Podlaskie Centrum Psychogeriatrii
NOT_YET_RECRUITING
Bialystok
MentalMEDIC
NOT_YET_RECRUITING
Bielsko-biala
Centrum Badan Klinicznych PI-House sp. z o.o.
NOT_YET_RECRUITING
Gdansk
Diamond Clinic
NOT_YET_RECRUITING
Krakow
NZOZ Psychiatrycznej Mentis
NOT_YET_RECRUITING
Leszno
Centrum Medyczne Luxmed
NOT_YET_RECRUITING
Lublin
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
NOT_YET_RECRUITING
Poznan
Centrum Medyczne Euromedis
NOT_YET_RECRUITING
Szczecin
Medical Concierge Centrum Medyczne
NOT_YET_RECRUITING
Warsaw
Centrum Medyczne Ginemedica
NOT_YET_RECRUITING
Wroclaw
Clinhouse Centrum Medyczne
NOT_YET_RECRUITING
Zabrze
Puerto Rico
SCB Research Center
NOT_YET_RECRUITING
Bayamón
Republic of Korea
Korea University Ansan Hospital
NOT_YET_RECRUITING
Ansan-si
Chonnam National University Hospital
NOT_YET_RECRUITING
Gwangju
Jeju National University Hospital
NOT_YET_RECRUITING
Jeju City
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Konkuk University Medical Center
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Spain
Hospital Clínic de Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Institucion Hosp Hestia Palau
NOT_YET_RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Infanta Leonor
NOT_YET_RECRUITING
Madrid
Centro de Atención Integral La Corredoria
NOT_YET_RECRUITING
Oviedo
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
NOT_YET_RECRUITING
Vitoria-gasteiz
Complejo Asistencial de Zamora
NOT_YET_RECRUITING
Zamora
Taiwan
Keelung Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Keelung
Chung Shan Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
Cheng Hsin General Hospital
NOT_YET_RECRUITING
Taipei
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Medical University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING
Taoyuan District
United Kingdom
Edinburgh Royal Infirmary
NOT_YET_RECRUITING
Edinburgh
Devon Partnership Trust
NOT_YET_RECRUITING
Exeter
Queen Elizabeth University Hospital
NOT_YET_RECRUITING
Glasgow
Clerkenwell Health - London - Welbeck Street
NOT_YET_RECRUITING
London
The Maudsley Hospital
NOT_YET_RECRUITING
London
Queen's Medical Centre, Nottingham University Hospitals
NOT_YET_RECRUITING
Nottingham
St Bartholomew's Medical Centre
NOT_YET_RECRUITING
Oxford
Warneford Hospital
NOT_YET_RECRUITING
Oxford
Atlantic Medical
NOT_YET_RECRUITING
Penzance
Woodstock Bower Surgery
NOT_YET_RECRUITING
Rotherham
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2028-02
Participants
Target number of participants: 1000
Treatments
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneously (SC) + standard of care (SoC).
Experimental: Brenipatide Dose 2
Brenipatide administered SC + SoC
Experimental: Brenipatide Dose 3
Brenipatide administered SC + SoC
Placebo_comparator: Placebo
Placebo administered SC + SoC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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