A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) (VENTURA-LT)
Last Updated   April 24, 2024 - 21:06
OVERVIEW
-
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
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
CONDITIONS
- Depressive disorder, major
ELIGIBILITY
Inclusion Criteria:
Transferred-entry participants:-Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent studyDirect-entry participants:* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* 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
* Must be an outpatient at open-label treatment phase baseline
* 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)Direct-entry and Transferred-entry Participants:-Participants should not take any prohibited medication or food supplements
Exclusion Criteria:
Transferred-entry Participants:* Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
* Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessmentsDirect-entry Participants:* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
DETAILS
LOCATIONS
Country (18) | City or Province (143) | Status |
United States | Allentown, PA Lehigh Center for Clinical Research |
RECRUITING
|
United States | Anaheim, CA Advanced Research Center Inc |
RECRUITING
|
United States | Bellevue, WA Northwest Clinical Research Center |
RECRUITING
|
United States | Berwyn, IL Research Network America |
COMPLETED
|
United States | Birmingham, AL University of Alabama at Birmingham - The Kirklin Clinic |
RECRUITING
|
United States | Buffalo, NY Erie County Medical Center |
COMPLETED
|
United States | Charlotte, NC New Hope Clinical Research |
RECRUITING
|
United States | Chicago, IL Chicago Research Center |
RECRUITING
|
United States | Cincinnati, OH Patient Priority Clinical Sites LLC |
RECRUITING
|
United States | Clearwater, FL Innovative Research of West Florida, Incorporated |
COMPLETED
|
United States | Clermont, FL Vertex Research Group, Inc |
RECRUITING
|
United States | Clinton, UT Alpine Research Organization |
RECRUITING
|
United States | Colorado Springs, CO MCB Clinical Research Centers, LLC |
RECRUITING
|
United States | Columbus, OH Wexner Medical Center at the Ohio State University |
RECRUITING
|
United States | Coral Springs, FL CNS Clinical Research Group |
RECRUITING
|
United States | Dallas, TX UT Southwestern Medical Center |
RECRUITING
|
United States | Dayton, OH Midwest Clinical Research Center |
RECRUITING
|
United States | Edmond, OK Conrad Clinical Research |
RECRUITING
|
United States | Elgin, IL Revive Research Institute |
RECRUITING
|
United States | Farmington, CT University of Connecticut Health Center |
RECRUITING
|
United States | Fort Myers, FL Gulfcoast Medical Research Center |
RECRUITING
|
United States | Fort Worth, TX North Texas Clinical Trials |
RECRUITING
|
United States | Gainesville, FL Sarkis Clinical Trials |
RECRUITING
|
United States | Gaithersburg, MD CBH Health |
RECRUITING
|
United States | Glendale, CA Behavioral Research Specialists LLC |
RECRUITING
|
United States | Hialeah, FL Amedica Research Institute Inc |
RECRUITING
|
United States | Hialeah, FL Galiz Research |
RECRUITING
|
United States | Hialeah, FL New Life Medical Research Center, Inc. |
RECRUITING
|
United States | Lincoln, NE Premier Psychiatric Research Institute, LLC |
COMPLETED
|
United States | Long Beach, CA Asclepes Research |
RECRUITING
|
United States | Media, PA Suburban Research Associates |
RECRUITING
|
United States | Methuen, MA ActivMed Practices and Research |
COMPLETED
|
United States | Miami Gardens, FL Meridian International Research |
RECRUITING
|
United States | Miami Lakes, FL University of Miami |
COMPLETED
|
United States | Miami, FL A Plus Research |
RECRUITING
|
United States | Miami, FL Ezy Medical Research |
RECRUITING
|
United States | Miami, FL Felicidad Medical Research |
RECRUITING
|
United States | Miami, FL Florida Research Center Inc. |
RECRUITING
|
United States | Miami, FL Global Medical Institutes |
RECRUITING
|
United States | Miami, FL LCC Medical Research Institute, Inc |
RECRUITING
|
United States | Miami, FL Pharmax Research Clinic Inc |
RECRUITING
|
United States | Miami, FL Vital Care Research |
RECRUITING
|
United States | Monroe, LA Clinical Trials of America |
RECRUITING
|
United States | Monroe, NC Monroe Biomedical Research |
RECRUITING
|
United States | Mount Kisco, NY Bioscience Research LLC |
RECRUITING
|
United States | Murray, UT Cedar Psychiatry |
RECRUITING
|
United States | New York, NY Fieve Clinical Research, Inc. |
RECRUITING
|
United States | New York, NY Manhattan Behavioral Medicine |
RECRUITING
|
United States | North Bay Village, FL Bravo Health Care Center |
RECRUITING
|
United States | O'Fallon, MO Psychiatric Care and Research Center (PCRC) |
RECRUITING
|
United States | Oceanside, CA Excell Research Inc |
RECRUITING
|
United States | Ocoee, FL K2 Medical Research |
RECRUITING
|
United States | Oklahoma City, OK Paradigm Research Professionals, LLC |
RECRUITING
|
United States | Oklahoma City, OK Sooner Clinical Research |
RECRUITING
|
United States | Orange City, FL Medical Research Group of Central Florida |
COMPLETED
|
United States | Orlando, FL Combined Research Orlando |
RECRUITING
|
United States | Philadelphia, PA University of Pennsylvania - Perelman School of Medicine |
RECRUITING
|
United States | Port Saint Lucie, FL CDC Research Institute LLC |
RECRUITING
|
United States | Rancho Cucamonga, CA Prospective Research Innovations Inc |
RECRUITING
|
United States | Rochester, NY Finger Lakes Clinical Research |
RECRUITING
|
United States | Saint Charles, MO Midwest Research Group |
RECRUITING
|
United States | Santa Ana, CA Syrentis Clinical Research |
RECRUITING
|
United States | Santee, CA CMB Clinical Trials |
RECRUITING
|
United States | Sherman Oaks, CA California Neuroscience Research |
COMPLETED
|
United States | Temecula, CA Viking Clinical Research Ltd |
RECRUITING
|
United States | Tucson, AZ SW Biomedical Research LLC |
RECRUITING
|
United States | Tucson, AZ University of Arizona |
RECRUITING
|
United States | West Covina, CA Next Level Clinical Trials, LLC |
RECRUITING
|
Taiwan | Taipei Taipei Veterans General Hospital |
RECRUITING
|
Taiwan | Taipei City Taipei Medical University |
RECRUITING
|
Sweden | Goteborg Sahlgrenska Universitetssjukhuset |
RECRUITING
|
Sweden | Lund ProbarE i Lund AB |
RECRUITING
|
Sweden | Stockholm ProbarE i Stockholm AB |
RECRUITING
|
Sweden | Stockholm Studieenheten Akademiskt Specialistcentrum Stockholm |
RECRUITING
|
Spain | Barcelona, BA Hosp. Univ. Vall D Hebron |
RECRUITING
|
Spain | Barcelona, BA Institucion Hosp Hestia Palau |
RECRUITING
|
Spain | Madrid, MD Hosp. Univ. La Paz |
RECRUITING
|
Spain | Sabadell, BA Corporacio Sanitari Parc Tauli |
RECRUITING
|
South Korea | Gyeonggi-do, 41 Korea University Ansan Hospital |
RECRUITING
|
South Korea | Seoul Korea University Anam Hospital |
RECRUITING
|
South Korea | Seoul Kyung Hee University Medical Center |
RECRUITING
|
South Korea | Seoul Samsung Medical Center |
RECRUITING
|
South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
South Africa | Cape Town, WC Cape Town Clinical Research Centre |
RECRUITING
|
South Africa | Pretoria, GT Gert Bosch Pretoria South Africa |
RECRUITING
|
South Africa | Strand, WC Somerset West Clinical Research Unit |
RECRUITING
|
Slovakia | Banska Bystrica Psychomed-Svatosavsky, s.r.o. |
RECRUITING
|
Slovakia | Bojnice Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach |
RECRUITING
|
Slovakia | Koshice Epamed sro |
RECRUITING
|
Slovakia | Liptovsky Mikulas Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu |
RECRUITING
|
Slovakia | Rimavska Sobota Psychiatricka Ambulancia Psycholine S.R.O. |
RECRUITING
|
Slovakia | Vranov nad Toplou Crystal Comfort s.r.o. |
RECRUITING
|
Poland | Bialystok Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk |
RECRUITING
|
Poland | Bydgoszcz Clinsante Osrodek Badan Klinicznych |
RECRUITING
|
Poland | Gdansk Centrum Badan Klinicznych PI-House sp. z o.o. |
RECRUITING
|
Poland | Katowice Centrum Medyczne Care Clinic Katowice |
RECRUITING
|
Poland | Lodz Specjalistyczna Indywidualna Praktyka Lekarska |
RECRUITING
|
Poland | Poznan Filip Rybakowski Specjalistyczna Praktyka Lekarska |
RECRUITING
|
Poland | Suchy Las Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda |
RECRUITING
|
Poland | Torun Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard |
RECRUITING
|
Italy | Lecce AUSL LE di Lecce |
RECRUITING
|
Italy | Milano Ospedale San Raffaele |
RECRUITING
|
Italy | Siena Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte |
RECRUITING
|
Hungary | Budapest Semmelweis Egyetem |
RECRUITING
|
Hungary | Pecs PsychoTech Kft |
RECRUITING
|
France | Douai Cabinet Medical des Drs Prizac-Desbonnet Scottez |
RECRUITING
|
France | Nantes CHU de Nantes hotel Dieu |
RECRUITING
|
Czechia | Brno Psychiatricka ambulance, MUDr. Marta Holanova |
COMPLETED
|
Czechia | Kutna Hora Neuroterapie KH, s.r.o. |
RECRUITING
|
Czechia | Plzen A-Shine s.r.o. |
RECRUITING
|
Czechia | Prague 5 Praglandia s r o |
RECRUITING
|
Czechia | Praha 10 AD71 s.r.o. |
RECRUITING
|
Czechia | Praha 10 Clintrial s r o |
RECRUITING
|
Czechia | Praha 6 Medical Services Prague s.r.o. |
RECRUITING
|
Czechia | Praha 6 NeuropsychiatrieHK, s.r.o. |
RECRUITING
|
Czechia | Praha 8 Institut Neuropsychiatricke pece |
RECRUITING
|
China | Beijing, 11 Beijing Anding Hospital of Capital Medical University |
RECRUITING
|
Bulgaria | Cherven Bryag Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET |
RECRUITING
|
Bulgaria | Plovdiv Ambulatory Group practice for specialized help in psychiary Philipopolis ODD |
RECRUITING
|
Bulgaria | Plovdiv Medical Center Mentalcare OOD |
RECRUITING
|
Bulgaria | Ruse, 18 Mental Health Center - Rousse |
RECRUITING
|
Bulgaria | Sofia DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD |
RECRUITING
|
Bulgaria | Sofia MHC - Sofia, EOOD |
RECRUITING
|
Bulgaria | Sofia Medical Center St. Naum |
RECRUITING
|
Bulgaria | Varna, 03 Diagnostic Consulting Center Mladost - M Varna |
RECRUITING
|
Bulgaria | Veliko Tarnovo Mental Health Center - Veliko Tarnovo EOOD |
RECRUITING
|
Brazil | Fortaleza Universidade Federal do Ceara Hospital Universitario Walter Cantidio |
RECRUITING
|
Brazil | Rio de Janeiro, RJ Ruschel Medicina e Pesquisa Clínica Ltda |
RECRUITING
|
Brazil | Sao Paulo, SP BR Trials |
RECRUITING
|
Belgium | Alken, VLI Anima |
RECRUITING
|
Belgium | Sint Niklaas Vitaz |
RECRUITING
|
Australia | Frankston, VIC Peninsula Therapeutic & Research Group |
RECRUITING
|
Australia | Melbourne, VIC Albert Road Clinic |
RECRUITING
|
Argentina | Buenos Aires, B INSA Instituto de Neurociencias San Agustín |
RECRUITING
|
Argentina | Ciudad Autonoma Buenos Aires, B CENydET - Centro Neurobiologico y de Stress Traumatico |
RECRUITING
|
Argentina | Ciudad Autonoma de Buenos Aires, B Hospital Italiano de Buenos Aires |
RECRUITING
|
Argentina | Cordoba CEN Consultorios Especializados en Neurociencias |
RECRUITING
|
Argentina | Cordoba Centro Medico Luquez |
RECRUITING
|
Argentina | La Plata CENPIA |
RECRUITING
|
Argentina | La Plata Clinica Privada de Salud Mental Santa Teresa de Ávila |
RECRUITING
|
Argentina | Rosario C I A P Centro de investigacion y Asistencia en Psiquiatria |
RECRUITING
|
Argentina | Rosario Instituto Medico de La Fundacion Estudios Clinicos |
RECRUITING
|
Argentina | San Miguel de Tucuman Clinica Mayo de UMCB |
RECRUITING
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.