A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) (VENTUR

A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) (VENTURA-LT)

Last Updated February 12, 2025

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CR109218

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 3

3
Sites
179 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 study

Direct-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 assessments

Direct-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

Inclusion Criteria:

Transferred-entry participants:

More...

DETAILS

LOCATIONS

Locations in:

United States, Argentina, Australia, Belgium, Brazil, Bulgaria, China, Czechia, France, Hungary, Italy, South Korea, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Taiwan

Country (19)	City or Province (179)	Status
United States	Birmingham University of Alabama at Birmingham - The Kirklin Clinic	RECRUITING
United States	Tucson SW Biomedical Research LLC	RECRUITING
United States	Tucson University of Arizona	RECRUITING
United States	Anaheim Advanced Research Center Inc	RECRUITING
United States	Glendale Behavioral Research Specialists LLC	RECRUITING
United States	Long Beach Asclepes Research	RECRUITING
United States	Oceanside Excell Research Inc	RECRUITING
United States	Rancho Cucamonga Prospective Research Innovations Inc	COMPLETED
United States	San Diego University of California San Diego Medical Center	RECRUITING
United States	Santa Ana Syrentis Clinical Research	RECRUITING
United States	Santee CMB Clinical Trials	RECRUITING
United States	Sherman Oaks California Neuroscience Research	COMPLETED
United States	Temecula Viking Clinical Research Ltd	RECRUITING
United States	West Covina Next Level Clinical Trials, LLC	RECRUITING
United States	Colorado Springs MCB Clinical Research Centers LLC	RECRUITING
United States	Farmington University of Connecticut Health Center	RECRUITING
United States	Clearwater Innovative Research of West Florida, Incorporated	COMPLETED
United States	Clermont Vertex Research Group, Inc	RECRUITING
United States	Coral Springs CNS Clinical Research Group	RECRUITING
United States	Fort Myers Gulfcoast Medical Research Center	RECRUITING
United States	Hialeah New Life Medical Research Center, Inc.	RECRUITING
United States	Hialeah Amedica Research Institute Inc	RECRUITING
United States	Hialeah Galiz Research	RECRUITING
United States	Miami Gardens Meridian International Research	RECRUITING
United States	Miami Lakes University of Miami	COMPLETED
United States	Miami Vital Care Research	RECRUITING
United States	Miami Global Medical Institutes	RECRUITING
United States	Miami LCC Medical Research Institute Inc	RECRUITING
United States	Miami Pharmax Research Clinic Inc	RECRUITING
United States	Miami A Plus Research	RECRUITING
United States	Miami Florida Research Center Inc.	RECRUITING
United States	Miami Ezy Medical Research	RECRUITING
United States	Miami Felicidad Medical Research	RECRUITING
United States	North Bay Village Bravo Health Care Center	RECRUITING
United States	Ocoee K2 Medical Research	RECRUITING
United States	Orange City Medical Research Group of Central Florida	COMPLETED
United States	Orlando Combined Research Orlando	RECRUITING
United States	Port Saint Lucie CDC Research Institute LLC	RECRUITING
United States	Berwyn Research Network America	COMPLETED
United States	Chicago Chicago Research Center	RECRUITING
United States	Elgin Revive Research Institute	RECRUITING
United States	Marrero Tandem Clinical Research	RECRUITING
United States	Monroe Clinical Trials of America	RECRUITING
United States	Gaithersburg CBH Health	RECRUITING
United States	Methuen ActivMed Practices and Research	COMPLETED
United States	O'Fallon Psychiatric Care and Research Center (PCRC)	RECRUITING
United States	Saint Charles Midwest Research Group	RECRUITING
United States	Lincoln Premier Psychiatric Research Institute, LLC	COMPLETED
United States	Buffalo Erie County Medical Center	COMPLETED
United States	Mount Kisco Bioscience Research LLC	RECRUITING
United States	New York Manhattan Behavioral Medicine	RECRUITING
United States	New York Fieve Clinical Research Inc	RECRUITING
United States	Rochester Finger Lakes Clinical Research	RECRUITING
United States	Charlotte New Hope Clinical Research	RECRUITING
United States	Monroe Monroe Biomedical Research	COMPLETED
United States	Cincinnati Patient Priority Clinical Sites LLC	RECRUITING
United States	Cincinnati University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience	RECRUITING
United States	Columbus Wexner Medical Center at the Ohio State University	RECRUITING
United States	Dayton Midwest Clinical Research Center	RECRUITING
United States	Edmond Conrad Clinical Research	RECRUITING
United States	Oklahoma City Sooner Clinical Research	RECRUITING
United States	Oklahoma City Paradigm Research Professionals, LLC	RECRUITING
United States	Allentown Lehigh Center for Clinical Research	RECRUITING
United States	Media Suburban Research Associates	RECRUITING
United States	Philadelphia University of Pennsylvania - Perelman School of Medicine	RECRUITING
United States	Austin Austin Clinical Trial Partners	RECRUITING
United States	Dallas UT Southwestern Medical Center	RECRUITING
United States	Fort Worth North Texas Clinical Trials	RECRUITING
United States	Clinton Alpine Research Organization	RECRUITING
United States	Bellevue Northwest Clinical Research Center	RECRUITING
Argentina	Buenos Aires INSA Instituto de Neurociencias San Agustín	RECRUITING
Argentina	Ciudad Autonoma Buenos Aires CENydET - Centro Neurobiologico y de Stress Traumatico	RECRUITING
Argentina	Ciudad Autonoma de Buenos Aires STAT Research S A	RECRUITING
Argentina	Ciudad Autonoma de Buenos Aires CIPREC	RECRUITING
Argentina	Ciudad Autonoma de Buenos Aires Hospital Italiano de Buenos Aires	RECRUITING
Argentina	Ciudad de Mendoza Resolution	RECRUITING
Argentina	Cordoba CEN Consultorios Especializados en Neurociencias	RECRUITING
Argentina	Cordoba Fundacion Lennox	RECRUITING
Argentina	Cordoba Centro Medico Luquez	RECRUITING
Argentina	Córdoba Instituto Medico DAMIC	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
Argentina	Santiago del Estero Clinica El Jardin	RECRUITING
Australia	Frankston Peninsula Therapeutic & Research Group	RECRUITING
Australia	Melbourne Albert Road Clinic	RECRUITING
Australia	Melbourne The Alfred Hospital	RECRUITING
Belgium	Alken Anima	RECRUITING
Belgium	Sint Niklaas Vitaz	RECRUITING
Brazil	Curitiba Trial Tech Tecnologia em Pesquisas com Medicamentos	RECRUITING
Brazil	Fortaleza Universidade Federal do Ceara Hospital Universitario Walter Cantidio	RECRUITING
Brazil	Goiania Instituto Goiano de Neuropsiquiatria	RECRUITING
Brazil	Porto Alegre NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul	RECRUITING
Brazil	Rio de Janeiro Ruschel Medicina e Pesquisa Clínica Ltda	RECRUITING
Brazil	Sao Bernardo CEMEC - Centro Multidisciplinar de Estudos Clínicos	RECRUITING
Brazil	Sao Paulo BR Trials	RECRUITING
Brazil	São Paulo CPQuali Pesquisa Clinica LTDA ME	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 Mental Health Center - Rousse	RECRUITING
Bulgaria	Sofia Medical Center St. Naum	RECRUITING
Bulgaria	Sofia MHC - Sofia, EOOD	RECRUITING
Bulgaria	Sofia DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD	RECRUITING
Bulgaria	Sofia Medical Center Hera EOOD	RECRUITING
Bulgaria	Varna Diagnostic Consulting Center Mladost - M Varna	RECRUITING
Bulgaria	Veliko Tarnovo Mental Health Center - Veliko Tarnovo EOOD	RECRUITING
China	Beijing Beijing Anding Hospital of Capital Medical University	RECRUITING
China	Beijing Beijing Huilongguan Hospital	RECRUITING
China	Shanghai Shanghai Mental Health Center	RECRUITING
China	Tianjin Tianjin Anding Hospital	RECRUITING
Czechia	Brno Psychiatricka ambulance, MUDr. Marta Holanova	COMPLETED
Czechia	Klecany Narodni ustav dusevniho zdravi	RECRUITING
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 Clintrial s r o	RECRUITING
Czechia	Praha 10 AD71 s.r.o.	RECRUITING
Czechia	Praha 6 NeuropsychiatrieHK, s.r.o.	RECRUITING
Czechia	Praha 6 Medical Services Prague s.r.o.	RECRUITING
Czechia	Praha 8 Institut Neuropsychiatricke pece	RECRUITING
France	Douai Cabinet Medical des Drs Prizac-Desbonnet Scottez	RECRUITING
France	Nantes CHU de Nantes hotel Dieu	RECRUITING
Hungary	Budapest Semmelweis Egyetem	RECRUITING
Hungary	Kalocsa Dr Mathe es Tarsa Bt	RECRUITING
Hungary	Pecs PsychoTech Kft	RECRUITING
Italy	Milano Ospedale San Raffaele	RECRUITING
Italy	Siena Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte	RECRUITING
South Korea	Gyeonggi-do Korea University Ansan Hospital	RECRUITING
South Korea	Seoul Kyung Hee University Medical Center	RECRUITING
South Korea	Seoul Korea University Anam Hospital	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
South Korea	Seoul Seoul National University Hospital	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
Portugal	Braga Hospital de Braga	RECRUITING
Portugal	Lisboa Fund. Champalimaud	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
South Africa	Cape Town Cape Town Clinical Research Centre	RECRUITING
South Africa	Pretoria Gert Bosch Pretoria South Africa	RECRUITING
South Africa	Strand Somerset West Clinical Research Unit	RECRUITING
Spain	Barcelona Institucion Hosp Hestia Palau	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING
Spain	Madrid Hosp. Univ. La Paz	RECRUITING
Spain	Málaga Hosp. Regional Univ. de Malaga	COMPLETED
Spain	Sabadell Corporacio Sanitari Parc Tauli	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
Taiwan	Taichung China Medical University Hospital	RECRUITING
Taiwan	Taipei City Taipei Medical University	RECRUITING
Taiwan	Taipei Taipei Veterans General Hospital	RECRUITING
United States	Lafayette Sunwise Clinical Research	RECRUITING
United States	Upland Pacific Clinical Research Medical Group	RECRUITING
United States	Gainesville Sarkis Clinical Trials	COMPLETED
United States	Orlando APG Research LLC	TERMINATED
United States	Pompano Beach Quantum Laboratories	RECRUITING
United States	Bellaire West Houston Clinical Research Service	COMPLETED
United States	Murray Cedar Psychiatry	COMPLETED
Brazil	Sao Jose do Rio Preto Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base	RECRUITING
China	Guangzhou Guangdong Provincial People's Hospital	RECRUITING
Hungary	Gyongyos Bugat Pal Korhaz	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Palma de Mallorca Hosp. Univ. Son Espases	COMPLETED
Spain	Ponferrada Hosp. El Bierzo	RECRUITING

Geo Locations

33.52066, -86.80249

32.22174, -110.92648

33.83529, -117.9145

34.14251, -118.25508

33.76696, -118.18923

33.19587, -117.37948

34.1064, -117.59311

32.71533, -117.15726

33.74557, -117.86783

32.83838, -116.97392

34.15112, -118.44925

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38.83388, -104.82136

41.71982, -72.83204

27.96585, -82.8001

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25.90871, -80.30866

25.77427, -80.19366

25.84621, -80.15394

28.56917, -81.54396

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28.53834, -81.37924

27.29393, -80.35033

41.85059, -87.79367

41.85003, -87.65005

42.03725, -88.28119

29.89937, -90.10035

32.50931, -92.1193

39.14344, -77.20137

42.7262, -71.19089

38.81061, -90.69985

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40.8, -96.66696

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41.13967, -112.0505

47.61038, -122.20068

-34.61315, -58.37723

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-34.92145, -57.95453

-32.94682, -60.63932

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-38.14458, 145.12291

-37.814, 144.96332

50.87553, 5.30558

51.16509, 4.1437

-25.42778, -49.27306

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-30.03306, -51.23

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-3.36139, -42.41778

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43.26667, 24.1

42.15, 24.75

43.85639, 25.97083

42.69751, 23.32415

43.21667, 27.91667

43.08124, 25.62904

39.9075, 116.39723

31.22222, 121.45806

39.14222, 117.17667

49.19522, 16.60796

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50.08804, 14.42076

50.36667, 3.06667

47.21725, -1.55336

47.49801, 19.03991

46.52639, 18.98583

46.08333, 18.23333

45.46427, 9.18951

43.31822, 11.33064

37.58944, 126.76917

37.566, 126.9784

53.13333, 23.16433

53.1235, 18.00762

54.35205, 18.64637

50.25841, 19.02754

51.75, 19.46667

52.40692, 16.92993

52.47308, 16.87745

53.01375, 18.59814

41.55032, -8.42005

38.71667, -9.13333

48.73946, 19.15349

48.78511, 18.5864

48.6962603, 21.2285014

49.08061, 19.62218

48.38284, 20.02239

48.88836, 21.68479

-33.92584, 18.42322

-25.74486, 28.18783

-34.10687, 18.82751

41.38879, 2.15899

40.4165, -3.70256

36.72016, -4.42034

41.54329, 2.10942

57.70716, 11.96679

55.70584, 13.19321

59.33258, 18.0649

24.1469, 120.6839

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37.88576, -122.11802

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29.70579, -95.45883

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23.11667, 113.25

47.78257, 19.928

41.38879, 2.15899

39.56939, 2.65024

42.54664, -6.59619

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.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

33.52066, -86.80249

32.22174, -110.92648

32.22174, -110.92648

33.83529, -117.9145

34.14251, -118.25508

33.76696, -118.18923

33.19587, -117.37948

34.1064, -117.59311

32.71533, -117.15726

33.74557, -117.86783

32.83838, -116.97392

34.15112, -118.44925

33.49364, -117.14836

34.06862, -117.93895

38.83388, -104.82136

41.71982, -72.83204

27.96585, -82.8001

28.54944, -81.77285

26.27119, -80.2706

26.62168, -81.84059

25.8576, -80.27811

25.8576, -80.27811

25.8576, -80.27811

25.94298, -80.24452

25.90871, -80.30866

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

25.84621, -80.15394

28.56917, -81.54396

28.94888, -81.29867

28.53834, -81.37924

27.29393, -80.35033

41.85059, -87.79367

41.85003, -87.65005

42.03725, -88.28119

29.89937, -90.10035

32.50931, -92.1193

39.14344, -77.20137

42.7262, -71.19089

38.81061, -90.69985

38.78394, -90.48123

40.8, -96.66696

42.88645, -78.87837

41.20426, -73.72708

40.71427, -74.00597

40.71427, -74.00597

43.15478, -77.61556

35.22709, -80.84313

34.98543, -80.54951

39.12713, -84.51435

39.12713, -84.51435

39.96118, -82.99879

39.75895, -84.19161

35.65283, -97.4781

35.46756, -97.51643

35.46756, -97.51643

40.60843, -75.49018

39.91678, -75.38769

39.95233, -75.16379

30.26715, -97.74306

32.78306, -96.80667

32.72541, -97.32085

41.13967, -112.0505