Could a drug combo ease Alzheimer's agitation? large trial underway

NCT ID NCT07011732

Recruiting now Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether a combination of two drugs, KarXT and KarX-EC, can safely reduce agitation in people with Alzheimer's disease. About 352 adults will receive either the drug combo or a placebo for 14 weeks. The main goal is to see if agitation symptoms improve, as measured by a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: KarXT (xanomeline/trospium) plus KarX-EC (xanomeline enteric capsule)
What this could lead to: If it works, this could provide a new option to calm agitation in Alzheimer's patients, improving quality of life for them and their caregivers.
What could go wrong: This is still an experimental treatment. Even if effective, it only targets agitation, not the underlying Alzheimer's disease, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALZHEIMER DISEASE

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AVIX Investigacion Clinica
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Monterrey, Nuevo León, 64623, Mexico

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Advanced Neurology Epilepsy and Sleep Center
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El Paso, Texas, 79912, United States

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Advanced Research Center (ARC) - Anaheim
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Anaheim, California, 92805, United States

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Aiginiteio University Hospital
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Athens, Attikí, 115 28, Greece

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Asakayama Hospital
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Sakai, Osaka, 590-0018, Japan

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Athens Medical Center
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Athens, 15125, Greece

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Boca Clinical Trials Mexico S.C.
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Guadalajara, Jalisco, 44600, Mexico

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Boston Center for Memory
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Newton, Massachusetts, 02459, United States

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CBH Health
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Gaithersburg, Maryland, 20877, United States

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CECPAR - Centro de Estudos Clínicos do Paraná
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Curitiba, Paraná, 80030-310, Brazil

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CEN Centro Especializado en Neurociencias
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Córdoba, Córdoba Province, 5004, Argentina

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CPQuali Pesquisa Clínica
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São Paulo, 01228-000, Brazil

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Cai Ferate Clinical Hospital Constanta
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Constanța, 90123, Romania

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Campus Neurologico Senior
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Torres Vedras, 2560-280, Portugal

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Central States Research
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Tulsa, Oklahoma, 74136, United States

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Centre for Addiction & Mental Health
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Toronto, Ontario, M6J 1H4, Canada

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Lisbon, 1649-035, Portugal

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Centro Hospitalar do Alto Ave
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Guimarães, 4835-044, Portugal

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Centro Medico Luquez
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Córdoba, 5006, Argentina

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Chang Gung Medical Foundation-Linkou Branch
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Taoyuan, 333, Taiwan

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Chang Gung Memorial Hospital at Kaohsiung
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Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

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Clinica Universidad de Navarra
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Pamplona, 31008, Spain

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Clinica Viver - Centro de Desospitalizacao Humana
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São Paulo, 04020-060, Brazil

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Clinical Hospital Center Split
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Split, HR-21000, Croatia

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Clinical Psychiatric Hospital "Dr. Gheorghe Preda"
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Sibiu, 550082, Romania

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Clinical Research Institute S.C.
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Tlalnepantla, 54055, Mexico

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Combined Research Orlando (CRO)
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Orlando, Florida, 32807, United States

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Complejo Hospitalario Ruber Juan Bravo
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Madrid, 28006, Spain

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Eginition Hospital
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Athens, 11528, Greece

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Elixia MA
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Springfield, Massachusetts, 01103, United States

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Euromedica General Clinic of Thessaloniki
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Thessaloniki, 54645, Greece

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Five Towns Neurology PC -Woodmere - 923 Broadway
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Woodmere, New York, 11598-1739, United States

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Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, S2000DEJ, Argentina

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General Hospital Varazdin
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Varaždin, 42000, Croatia

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Global Medical Institutes LLC; Princeton Medical Institute
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Princeton, New Jersey, 08540, United States

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Hatano Kousei Hospital
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Hadano, Kanagawa, 257-0003, Japan

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Henry Dunant Hospital Center
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Athens, Attica, 115 26, Greece

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Hope Research Network - Miami
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Miami, Florida, 33166, United States

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Hospital Clinico San Carlos
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Madrid, 28040, Spain

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Hospital Clinico Universitario Virgen de La Victoria
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Málaga, 29010, Spain

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Hospital General Universitario de Elche
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Elche (alicante), 03203, Spain

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Hospital Moinhos de Vento
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Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

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Hospital Mutua Terrassa
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Terrassa, 8221, Spain

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Hospital Universitario De Rio Hortega
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Valladolid, 47012, Spain

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Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
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Salamanca, 37007, Spain

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Hospital Universitario de Saltillo
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Saltillo, Coahuila, 25000, Mexico

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Hospital Viamed Montecanal
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Zaragoza, 50012, Spain

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Hospital Victoria Eugenia de Sevilla
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Seville, 41009, Spain

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Imaging Endpoints
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Scottsdale, Arizona, 85258, United States

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Innovacion y Desarrollo en Ciencias de la Salud
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Mexico City, Mexico City, 14090, Mexico

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Instituto Privado Kremer
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Córdoba, 5004, Argentina

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Instituto de Pesquisa Clínica de Campinas
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Campinas, São Paulo, 13060-080, Brazil

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Institutul de Psihiatrie Socola
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Iași, 700282, Romania

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Kingfisher Cooperative
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Spokane, Washington, 99201, United States

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Klinicki Bolnicki Centar Rijeka
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Rijeka, 51000, Croatia

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Kuramitsu Hospital
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Fukuoka, 819-0037, Japan

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L2IP - Instituto de Pesquisas Clínicas
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Brasília, Federal District, 70200730, Brazil

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Local Institution - 1001
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La Plata, Buenos Aires, 1900, Argentina

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Mar del Plata, Buenos Aires, B7602CBM, Argentina

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Buenos Aires, C1428AQK, Argentina

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Sofia, 1202, Bulgaria

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Montreal, Quebec, H4A 3T2, Canada

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Hamilton, Ontario, L8M 1W9, Canada

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Ioannina, 45500, Greece

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Local Institution - 1250
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Kolkata, West Bengal, 700054, India

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Hyderabad, 500034, India

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Hyderabad, Telangana, 500082, India

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New Delhi, 110029, India

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Varanasi, Uttar Pradesh, 221005, India

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Ahmedabad, Gujarat, 380060, India

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Delhi, 110 095, India

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Shimotsuke-shi, Tochigi, 329-0498, Japan

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Local Institution - 1350
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Monterrey, Nuevo León, 66460, Mexico

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Mexico City, Mexico City, 14269, Mexico

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Mexico City, 10200, Mexico

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Local Institution - 1451
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Bucharest, 010825, Romania
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Bucharest, 060222, Romania
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Bucharest, 011241, Romania

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Local Institution - 1550
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Zagreb, City of Zagreb, 10000, Croatia

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Local Institution - 1553
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Zagreb, City of Zagreb, 10000, Croatia

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Zagreb, 10 090, Croatia

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Local Institution - 1602
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Miami, Florida, 33122, United States

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Local Institution - 1604
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Miami, Florida, 33186, United States
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Ocala, Florida, 34471, United States

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Local Institution - 1610
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Inwood, New York, 11096, United States

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Miami, Florida, 33135, United States

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Local Institution - 1622
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Maitland, Florida, 32751, United States

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Local Institution - 1630
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Colorado Springs, Colorado, 80907, United States
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Maitland, Florida, 32751, United States

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La Jolla, California, 92037, United States
Local Institution - 1639
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Torrance, California, 90505, United States
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Seattle, Washington, 98122, United States

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Local Institution - 1645
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Woodmere, New York, 11598-1739, United States
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Middletown, New Jersey, 07748, United States
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Columbia, South Carolina, 29205, United States
Local Institution - 1655
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Marrero, Louisiana, 70072, United States

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Local Institution - 1663
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Foxborough, Massachusetts, 02035-1309, United States

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Local Institution - 1666
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Merritt Island, Florida, 32952, United States

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Local Institution - 1755
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London, Ontario, N6A 5W9, Canada
Local Institution - 1800
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Shanghai, Shanghai Municipality, 200025, China
Local Institution - 1808
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Tianjin, 300350, China
Local Institution - 1810
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Beijing, Beijing Municipality, 100088, China

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Local Institution - 1819
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Chengdu, Sichuan, 610041, China

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London Health Sciences Centre-Victoria Campus
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London, Ontario, N6A 5W9, Canada

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Mayflower Clinical Research
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South Dartmouth, Massachusetts, 02747, United States

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Medical Center Medconsult Pleven OOD
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Pleven, 5800, Bulgaria

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Medical Center Mladost
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Varna, 9020, Bulgaria

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Medical Center Sveti Naum EOOD
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Sofia, 1113, Bulgaria

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Mental Health Center of Xi'an City
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Xian, Shanxi, 710061, China

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Mid Hudson Medical Research
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New Windsor, New York, 12553, United States

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Nanjing Drum Tower hospital
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Nanjing, Jiangsu, 210008, China

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National Cheng Kung University Hospital
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Tainan, Taiana, 704, Taiwan

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National Hospital Organization Hizen Psychiatric Center
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Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192, Japan

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National Taiwan University Hospital
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Taipei, 100229, Taiwan

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NeuroBehavioral Medicine Group
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Bloomfield Hills, Michigan, 48302, United States

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Neurociencias PRISMA A.C.
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San Luis Potosí City, 78216, Mexico

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Nippon Medical School Hospital
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Bunkyo-ku, Tokyo, 113-8603, Japan

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Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

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Oakland Medical Research
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Troy, Michigan, 48085, United States

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Okayama City General Medical Center Okayama City Hospital
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Okayama, 700-8557, Japan

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Ontario Shores Centre For Mental Health Sciences
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Whitby, Ontario, L1N 5S9, Canada

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Oroitu CAE
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Getxo, Bizkaia, 48993, Spain

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Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova
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Razgrad, 7200, Bulgaria

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PUCTrials
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Curitiba, Paraná, 80230-130, Brazil

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Peking University Sixth Hospital
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Haidian District, Beijing Municipality, 100191, China

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Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
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Bucharest, 40874, Romania

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Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Bucharest, Bucharest, 041919, Romania

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Progressive Medical Research
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Port Orange, Florida, 32127, United States

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Rainbow and Sea Hospital
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Karatsu-shi, Saga-ken, 847-0031, Japan

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Redbird Research
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Las Vegas, Nevada, 89119, United States

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Ruschel Medicina e Pesquisa Clínica
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Rio de Janeiro, 22270-060, Brazil

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Shenzhen Kangning Hospital
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Shenzhen, Guangdong, 518118, China

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Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hangzhou, 310016, China

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Spitalul de Psihiatrie și Neurologie Brașov
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Sanpetru /Brasov, 507190, Romania

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Sunnybrook Research Institute
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Toronto, Ontario, M4N 3M5, Canada

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Sunwise Clinical Research
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Walnut Creek, California, 94596, United States

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Taipei Veterans General Hospital
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Taipei, 112, Taiwan

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Teikyo University Mizonokuchi Hospital
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Kawasaki, Kanagawa, 213-8507, Japan

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The Affiliated Brain Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, 0, China

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The First Affiliated Hospital of Chongqing Medical University
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Chongqing, Chongqing Municipality, 630014, China

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The First Affiliated Hospital of Kunming Medical University
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Kunming, 650032, China

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The First Affiliated Hospital of Zhejiang University
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Hangzhou, Zhejiang, 310003, China

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The Memory Clinic
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Bennington, Vermont, 05201-9810, United States

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The Neurology Group
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Pomona, California, 91767, United States

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The Second Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangzhou Province, 510260, China

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Tianjin Anding Hospital
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Tianjin, Tianjin Municipality, 300074, China

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Unidade Local de Saúde de Coimbra, E.P.E.
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Coimbra, 3049, Portugal

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Unidade Local de Saúde de Matosinhos SA
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Senhora da Hora, 4464-513, Portugal

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University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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Chaïdári, Attikí, 124 62, Greece

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University Hospital of Patras
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Pátrai, Achaḯa, 26504, Greece

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Wasatch Clinical Research, LLC
RECRUITING

Salt Lake City, Utah, 84107, United States

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Xiangya Hospital Central South University
RECRUITING

Changsha, Hunan, 410008, China

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Xuanwu Hospital Capital Medical University
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Beijing, Beijing Municipality, 100053, China

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