New shot could help heavy drinkers cut back
NCT ID NCT07219953
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 8 times
Summary
This study tests an experimental medicine called brenipatide to see if it helps adults with alcohol use disorder drink less and reduce cravings. About 1,100 participants will receive either the drug or a placebo by injection for nearly a year. The goal is to find a safe, effective treatment to help people control their drinking.
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 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 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: * Participant must be a minimum of 20 years of age for the investigative sites in Japan. * Are seeking treatment and are motivated to stop or cut down on drinking. * 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 Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the 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 evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine. * Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months * Have either of the following: * history of advanced liver disease, including advanced liver fibrosis \[Stage 3\] or cirrhosis \[Stage 4\], based on prior biomarkers, imaging or liver biopsy, OR * history of acute or alcohol-associated hepatitis based on prior liver biopsy. * Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.
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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
116 sites in 8 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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ANIMA Research
RECRUITINGDiepenbeek, 3590, Belgium
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Accel Research Sites - Lakeland Clinical Research Unit
RECRUITINGLakeland, Florida, 33803, United States
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Adams Clinical Boston
RECRUITINGBoston, Massachusetts, 02116, United States
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Adams Clinical Bronx
RECRUITINGThe Bronx, New York, 10461, United States
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Adams Clinical Dallas
RECRUITINGDeSoto, Texas, 75115, United States
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Ai Sakura Clinic
RECRUITINGFukuoka, 810-0001, Japan
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Arata Clinic
RECRUITINGNagasaki, 852-8137, Japan
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Artemis Institute for Clinical Research
RECRUITINGRiverside, California, 92503, United States
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Artemis Institute for Clinical Research
RECRUITINGSan Diego, California, 92123, United States
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Avera Research Institute - Sioux Falls
RECRUITINGSioux Falls, South Dakota, 57108, United States
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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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Biopharma Informatic, LLC
RECRUITINGHouston, Texas, 77043, United States
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Brown University School of Public Health
RECRUITINGProvidence, Rhode Island, 02903, United States
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Chang Gung Medical Foundation-Linkou Branch
RECRUITINGTaoyuan, 333, Taiwan
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Changhua Christian Hospital
RECRUITINGChanghua County, 50006, Taiwan
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Charter Research - Orlando
RECRUITINGOrlando, Florida, 32803, United States
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China Medical University Hospital
RECRUITINGTaichung, 404332, Taiwan
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Chungbuk National University Hospital
RECRUITINGCheongju-si, 28644, South Korea
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Clerkenwell Health - Doncaster
RECRUITINGDoncaster, DN4 8QN, United Kingdom
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Clerkenwell Health - London - Baker Street
RECRUITINGLondon, W1U 6RP, United Kingdom
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Dedicated Research Site FutureMeds
RECRUITINGOffenbach, 63065, Germany
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First Affiliated Hospital of Kunming Medical University
RECRUITINGKunming, 650032, China
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FutureMeds GmbH
RECRUITINGBerlin, 10629, Germany
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Gachon University Gil Medical Center
RECRUITINGNamdong-gu, 21565, South Korea
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Gezondheidshuis De Gloed
RECRUITINGMachelen, 9870, Belgium
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Guangzhou Brain Hospital
RECRUITINGGuangzhou, 510370, China
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HMC Health Group - Meadows Centre for Health
RECRUITINGHounslow, TW4 7NR, United Kingdom
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Hallym University Sacred Heart Hospital
RECRUITINGAnyang-si, 14068, South Korea
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Hanyang University Guri Hospital
RECRUITINGGuri-si, 11923, South Korea
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Hanyang University Seoul Hospital
RECRUITINGSeoul, 04763, South Korea
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Headlands Research - Scottsdale
RECRUITINGScottsdale, Arizona, 85260, United States
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Hefei No.4 People's Hospital
RECRUITINGHefei, 230061, China
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Higashi Shinjuku Clinic
RECRUITINGShinjuku-ku, 169-0072, Japan
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Hillside Clinic Jingumae
RECRUITINGShibuya City, 150-0001, Japan
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Hiro Mental Clinic
RECRUITINGFukuoka, 810-0004, Japan
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Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
RECRUITINGHualien City, 970, Taiwan
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Huzhou Third Municipal Hospital
RECRUITINGHuzhou, 313000, China
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Inha University Hospital
RECRUITINGIncheon, 22332, South Korea
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Innovative Clinical Research
RECRUITINGLauderhill, Florida, 33319, United States
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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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K2 Medical Research ORLANDO
RECRUITINGMaitland, Florida, 32751, United States
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Keiai Clinic
RECRUITINGShinjuku-ku, 160-0004, Japan
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Klinische Forschung Dresden
RECRUITINGDresden, 01069, Germany
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Klinische Forschung Hamburg
RECRUITINGHamburg, 20253, Germany
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Klinische forschung Schwerin GmbH
RECRUITINGSchwerin, 19055, Germany
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Konyang University Hospital
RECRUITINGSeogu, 35365, South Korea
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Konyang University Hospital
RECRUITINGSeogu, 35365, South Korea
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Kormont
RECRUITINGKluisbergen, 9690, Belgium
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Kyungpook National University Hospital
RECRUITINGJunggu, 41944, South Korea
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Layton Medical Centre
RECRUITINGBlackpool, FY3 7EN, United Kingdom
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Life Arc Research Centers - Miami
RECRUITINGMiami, Florida, 33126, United States
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Life Medical Research Group Corp
RECRUITINGMiami Gardens, Florida, 33014, United States
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Mackay Memorial Hospital
RECRUITINGTaipei, 10449, Taiwan
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Maekawa Medical Clinic
RECRUITINGYokohama, 220-0004, Japan
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Maryland Treatment Centers - Avery Road Treatment Center
RECRUITINGRockville, Maryland, 20853, United States
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Maryland Treatment Centers - Mountain Manor Treatment Center
RECRUITINGBaltimore, Maryland, 21229, United States
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Meclinas
RECRUITINGMechelen, 2800, Belgium
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Medisch Centrum Saffrou
RECRUITINGOudenaarde, 9636, Belgium
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Modern Research Associates, PLLC
RECRUITINGDallas, Texas, 75231, United States
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Mounts Bay Medical Hub
RECRUITINGHayle, TR27 5DT, United Kingdom
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National Hospital Organization Hizen Psychiatric Medical Center
RECRUITINGYoshinogari-cho, Kanzaki-gun, 842-0192, Japan
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Newquay Health Centre
RECRUITINGNewquay, TR7 1RU, United Kingdom
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Noguchi Naika Clinic
RECRUITINGTokyo, 165-0031, Japan
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North Star Medical Research
RECRUITINGMiddleburg Heights, Ohio, 44130, United States
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Panthera Biopartners - Preston
RECRUITINGPreston, PR2 9QB, United Kingdom
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Penn Medicine: University of Pennsylvania Health System
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Psychiatric Hospital of Henan Province
RECRUITINGXinxiang, 453003, China
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Pusan National University Yangsan Hospital
RECRUITINGBusan, 50612, South Korea
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Queen Elizabeth University Hospital
RECRUITINGGlasgow, G51 4TF, United Kingdom
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Rainbow and Sea Hospital
RECRUITINGKaratsu, 847-0031, Japan
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Re:Cognition Health
RECRUITINGFairfax, Virginia, 22031, United States
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Re:Cognition Health - Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Sakurazaka Clinic SophyAnce
RECRUITINGTokyo, 106-0032, Japan
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Samoncho Clinic
RECRUITINGShinjuku, 160-0017, Japan
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Seoul National University Bundang Hospital
RECRUITINGSeongnam, 13620, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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Shandong Mental Health Center
RECRUITINGJinan, 250012, China
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Shanghai Mental Health Center
RECRUITINGShanghai, 200030, China
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Shenzhen Kangning Hospital
RECRUITINGShenzhen, 518003, China
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Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
RECRUITINGHangzhou, 310016, China
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St Pancras Clinical Research
RECRUITINGLondon, EC2Y 8EA, United Kingdom
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St Pancras Clinical Research - Eastbourne
RECRUITINGEastbourne, BN23 5UZ, United Kingdom
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Tatsuta Clinic
RECRUITINGKobe, 651-0097, Japan
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The Affiliated hospital of Southwest Medical University
RECRUITINGSichuan, 646000, China
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The Affilicated Kangning Hospital of Ningbo University
RECRUITINGNingbo, 315201, China
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The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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The Catholic University of Korea, Uijeongbu St. Mary's Hospital
RECRUITINGUijeongbu-si, 11765, South Korea
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The First Hospital of Hebei Medical University
RECRUITINGShijiazhuang, 050031, China
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The Fourth Hospital of Harbin Medical University
RECRUITINGHarbin, 150001, China
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The Fourth People's Hospital of Chengdu
RECRUITINGChengdu, 610036, China
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The Second People's Hospital of Hunan Province
RECRUITINGChangsha, 410007, China
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The Second Xiangya Hospital of Central South University
RECRUITINGChangsha, 410011, China
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The Seventh People's Hospital of Hangzhou
RECRUITINGHangzhou, 310000, China
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Tokyo-Eki Center-building Clinic
RECRUITINGChūōku, 103-0027, Japan
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Tri-Service General Hospital
RECRUITINGTaipei, 114, Taiwan
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Tsukuba University Hospital
RECRUITINGTsukuba, 305-8576, Japan
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UCLA Clinical & Translational Research Center (CTRC)
RECRUITINGLos Angeles, California, 90095, United States
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UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
RECRUITINGSan Francisco, California, 94158, United States
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Velocity Clinical Research, Berlin
RECRUITINGBerlin, 10787, Germany
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Wellness Research Center
RECRUITINGMiami, Florida, 33135, United States
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West China Hospital, Sichuan University
RECRUITINGCheng Du Shi, 610041, China
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Wickersley Health Centre - Clifton Medical Centre
RECRUITINGRotherham, S65 1DA, United Kingdom
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Woodland International Research Group
RECRUITINGLittle Rock, Arkansas, 72211, United States
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Wuhu Hospital of Beijing Anding hospital
RECRUITINGWuhu, 242407, China
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Xi An Mental Health Center
RECRUITINGXi'an, 710061, China
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Xiamen Xianyue Hospital
RECRUITINGXiamen, 361012, China
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Xianyang Hospital of Yan'an University
RECRUITINGXianyang, 712000, China
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Yokogawa Ekimae Clinic
RECRUITINGNishi, 733-0011, Japan
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Zentralinstitut für Seelische Gesundheit
RECRUITINGMannheim, 68159, Germany
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Zhejiang Provincial People's Hospital
RECRUITINGHangzhou, 310014, China
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Zhenjiang Mental Health Center
RECRUITINGZhenjiang, 212000, China
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Zhumadian Psychiatric Hospital
RECRUITINGZhumadian, 463000, China
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Other studies related to the condition(s) this trial covers.
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