A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (VENTURA-1)
Last Updated   April 24, 2024 - 21:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
SUMMARY
Depression is a common and serious psychiatric disorder which is a leading cause of disability worldwide and is associated with elevated mortality and suicide risk. Aticaprant (JNJ-67953964) is a once daily, highly selective kappa opioid receptor (KOR) antagonist, with demonstrated selectivity over mu opioid receptor (MOR) and delta opioid receptor (DOR) being developed for adjunctive treatment of major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+). The study consists of a screening phase (up to 30 days prior to randomization), double-blind treatment phase (43 days), and follow-up phase (up to 14 days). The total duration of the study will be up to 87 days. Safety evaluations including adverse events, physical examinations, urine drug test, alcohol breath tests, and clinical laboratory tests will be assessed at specific time points during this study.
CONDITIONS
- Anhedonia
- Depressive disorder, major
ELIGIBILITY
Inclusion Criteria:
* Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
* Have a Hamilton Depression Rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments
* Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT). Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression. An inadequate response is defined as less than(<) 50% reduction in depressive symptom severity but with some improvement (>0%) (ie, there may be minimal to moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function), as assessed by the MGH ATRQ
* Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine at a stable dose for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression
* Participant's current major depressive episode, and antidepressant treatment response in the current depressive episode, must all be confirmed by the site independent qualification assessment
Exclusion Criteria:
* Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI (that is, the one presumed to be continued in the treatment phase) assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
* Has had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation device
* Has current, or a history (past 6 months), of seizures
* Has a current homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the Screening Phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 or Item 5, or a history of suicidal behavior within the past 6 months prior to the start of the Screening Phase. Participants reporting suicidal ideation with intent to act or suicidal behavior at baseline should be excluded
* Has one or more of the following diagnoses: a) A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia; b) A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c) A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders
DETAILS
Depression is a common and serious psychiatric disorder which is a leading cause of disability worldwide and is associated with elevated mortality and suicide risk. Aticaprant (JNJ-67953964) is a once daily, highly selective kappa opioid receptor (KOR) antagonist, with demonstrated selectivity over mu opioid receptor (MOR) and delta opioid receptor (DOR) being developed for adjunctive treatment of major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+). The study consists of a screening phase (up to 30 days prior to randomization), double-blind treatment phase (43 days), and follow-up phase (up to 14 days). The total duration of the study will be up to 87 days. Safety evaluations including adverse events, physical examinations, urine drug test, alcohol breath tests, and clinical laboratory tests will be assessed at specific time points during this study.
LOCATIONS
Country (13) | City or Province (118) | Status |
United States | Anaheim, CA Advanced Research Center Inc |
RECRUITING
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United States | Bellaire, TX West Houston Clinical Research Service |
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United States | Bellevue, WA Northwest Clinical Research Center |
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United States | Berwyn, IL Research Network America |
COMPLETED
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United States | Bronx, NY Montefiore Medical Center PRIME |
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United States | Charlottesville, VA University of Virginia |
RECRUITING
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United States | Chicago, IL Chicago Research Center |
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United States | Cincinnati, OH Patient Priority Clinical Sites LLC |
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United States | Cincinnati, OH University of Cincinnati Medical Center |
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United States | Clearwater, FL Innovative Research of West Florida, Incorporated |
COMPLETED
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United States | Clermont, FL Vertex Research Group, Inc |
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United States | Clinton, UT Alpine Research Organization |
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United States | Culver City, CA Proscience Research Group |
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United States | Dayton, OH Midwest Clinical Research Center |
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United States | Farmington, CT University of Connecticut Health Center |
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United States | Fort Myers, FL Gulfcoast Medical Research Center |
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United States | Fort Worth, TX North Texas Clinical Trials |
RECRUITING
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United States | Friendswood, TX Bay Area Clinical Services |
COMPLETED
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United States | Garfield Heights, OH Charak Center for Health and Wellness |
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United States | Glendale, CA Behavioral Research Specialists LLC |
RECRUITING
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United States | Hialeah, FL Amedica Research Institute Inc |
RECRUITING
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United States | Hialeah, FL Convenient Medical Center |
COMPLETED
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United States | Hialeah, FL Galiz Research |
RECRUITING
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United States | Hialeah, FL New Life Medical Research Center, Inc. |
RECRUITING
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United States | Houston, TX Clinical Trial Network - Houston |
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United States | Kansas City, KS University of Kansas Medical Center Research Institute |
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United States | Long Beach, CA Asclepes Research |
RECRUITING
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United States | Media, PA Suburban Research Associates |
RECRUITING
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United States | Methuen, MA ActivMed Practices and Research |
COMPLETED
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United States | Miami Gardens, FL Meridian International Research |
RECRUITING
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United States | Miami Lakes, FL University of Miami |
COMPLETED
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United States | Miami, FL A Plus Research |
RECRUITING
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United States | Miami, FL Pharmax Research Clinic Inc |
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United States | Monroe, LA Clinical Trials of America |
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United States | Mount Kisco, NY Bioscience Research LLC |
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United States | New York, NY Fieve Clinical Research, Inc. |
RECRUITING
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United States | O'Fallon, MO Psychiatric Care and Research Center (PCRC) |
RECRUITING
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United States | Oceanside, CA Excell Research Inc |
RECRUITING
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United States | Orange City, FL Medical Research Group of Central Florida |
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United States | Philadelphia, PA University of Pennsylvania - Perelman School of Medicine |
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United States | Rochester, NY Finger Lakes Clinical Research |
RECRUITING
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United States | Santa Ana, CA Syrentis Clinical Research |
RECRUITING
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United States | Tampa, FL USF, Department of Psychiatry and Behavioral Neurosciences |
RECRUITING
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United States | Temecula, CA Viking Clinical Research Ltd |
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United States | Tucson, AZ SW Biomedical Research LLC |
RECRUITING
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United States | Tucson, AZ University of Arizona |
RECRUITING
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Sweden | Goteborg Sahlgrenska Universitetssjukhuset |
RECRUITING
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Sweden | Lund ProbarE i Lund AB |
RECRUITING
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Sweden | Stockholm ProbarE i Stockholm AB |
RECRUITING
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Sweden | Stockholm Studieenheten Akademiskt Specialistcentrum Stockholm |
RECRUITING
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Spain | Barcelona, BA Hosp. Clinic de Barcelona |
RECRUITING
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Spain | Barcelona, BA Hosp. Univ. Vall D Hebron |
RECRUITING
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Spain | Barcelona, BA Institucion Hosp Hestia Palau |
RECRUITING
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Spain | Madrid, MD Hosp. Univ. La Paz |
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Spain | Málaga Hosp. Regional Univ. de Malaga |
RECRUITING
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Spain | Palma de Mallorca Hosp. Univ. Son Espases |
RECRUITING
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Spain | Ponferrada Hosp. El Bierzo |
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Spain | Sabadell, BA Corporacio Sanitari Parc Tauli |
RECRUITING
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Spain | Vigo, PO Hosp. Alvaro Cunqueiro |
RECRUITING
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Spain | Vitoria Hosp. Psiquiatrico Alava |
RECRUITING
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Portugal | Braga, Braga Hospital de Braga |
SUSPENDED
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Portugal | Lisboa Fundacao Champalimaud |
RECRUITING
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Portugal | Lisboa Hospital CUF Inf. Santo |
RECRUITING
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Poland | Belchatow Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski |
RECRUITING
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Poland | Bialystok Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk |
RECRUITING
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Poland | Gdansk Centrum Badan Klinicznych PI-House sp. z o.o. |
RECRUITING
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Poland | Lodz SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi |
RECRUITING
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Poland | Lodz Specjalistyczna Indywidualna Praktyka Lekarska |
RECRUITING
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Poland | Poznan Osrodek Badan Klinicznych CROMED |
RECRUITING
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Poland | Torun Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard |
RECRUITING
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Italy | Bergamo Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) |
RECRUITING
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Italy | Catanzaro Azienda Ospedaliero Universitaria Mater Domini |
RECRUITING
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Italy | Lecce AUSL LE di Lecce |
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Italy | Milano ASST Fatebenefratelli Sacco |
RECRUITING
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Italy | Milano Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico |
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Italy | Milano Ospedale San Raffaele |
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Italy | Siena Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte |
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Hungary | Budapest Obudai Egeszsegugyi Centrum Kft |
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Hungary | Budapest Semmelweis Egyetem |
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Hungary | Gyongyos Bugat Pal Korhaz |
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Hungary | Kalocsa Dr Mathe es Tarsa Bt |
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Hungary | Pecs PsychoTech Kft |
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Hungary | Szekszárd Tolna Megyei Balassa Janos Korhaz |
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Czechia | Klecany Narodni ustav dusevniho zdravi |
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Czechia | Plzen A-Shine s.r.o. |
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Czechia | Prague 5 Praglandia s r o |
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Czechia | Praha 10 AD71 s.r.o. |
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Czechia | Praha 10 Clintrial s r o |
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Czechia | Praha 6 NeuropsychiatrieHK, s.r.o. |
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Czechia | Usti nad Labem Psychiatricka ordinace |
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Bulgaria | Cherven Bryag Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET |
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Bulgaria | Plovdiv Ambulatory Group practice for specialized help in psychiary Philipopolis ODD |
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Bulgaria | Plovdiv Medical Center Mentalcare OOD |
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Bulgaria | Ruse, 18 Mental Health Center - Rousse |
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Bulgaria | Sofia Medical Center St. Naum |
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Bulgaria | Veliko Tarnovo Mental Health Center - Veliko Tarnovo EOOD |
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Brazil | Fortaleza Universidade Federal do Ceara Hospital Universitario Walter Cantidio |
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Brazil | Goiania Instituto Goiano de Neuropsiquiatria |
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Brazil | Porto Alegre NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul |
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Brazil | Rio de Janeiro, RJ Ruschel Medicina e Pesquisa Clínica Ltda |
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Brazil | Sao Jose do Rio Preto, SP Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base |
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Brazil | Sao Paulo, SP BR Trials |
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Brazil | São Bernardo do Campo, SP CEMEC - Centro Multidisciplinar de Estudos Clínicos |
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Brazil | São Paulo, SP CPQuali Pesquisa Clinica LTDA ME |
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Belgium | Alken, VLI Anima |
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Belgium | Bruxelles, BRU C.H.U. Brugmann |
RECRUITING
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Belgium | Duffel Pz Duffel |
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Belgium | Sint Niklaas Vitaz |
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Australia | Frankston, VIC Peninsula Therapeutic & Research Group |
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Australia | Melbourne, VIC Albert Road Clinic |
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Argentina | Ciudad Autonoma Buenos Aires, B CENydET - Centro Neurobiologico y de Stress Traumatico |
RECRUITING
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Argentina | Ciudad Autonoma de Buenos Aires, B CIPREC |
RECRUITING
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Argentina | Ciudad Autonoma de Buenos Aires, B Hospital Italiano |
RECRUITING
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Argentina | Ciudad Autonoma de Buenos Aires, B STAT Research S.A. |
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Argentina | Ciudad de Mendoza Resolution |
RECRUITING
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Argentina | Cordoba, X Fundacion Lennox |
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Argentina | La Plata CENPIA |
RECRUITING
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Argentina | Rosario Instituto Medico de La Fundacion Estudios Clinicos |
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