A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With M

A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (VENTURA-2)

Last Updated August 15, 2024

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CR109230

OVERVIEW

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

3
Sites
125 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 MDD with ANH+. The total duration of the study will be up to 87 days. Safety evaluation 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

Depressive Disorder, Major
Anhedonia

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 (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
* 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 structural 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
* 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 (at or above the minimum therapeutic dose per Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH-ATRQ] 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 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 diagnostic and statistical manual of mental disorders-5th edition (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 (that is, at least 7 treatments), 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 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent), 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 diagnostic and statistical manual of mental disorders-5th edition (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 major depressive disorder (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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Argentina, Brazil, Bulgaria, Canada, China, Czechia, France, South Korea, Poland, Slovakia, South Africa, Taiwan, United Kingdom

Country (14)	City or Province (125)	Status
United States	Birmingham University of Alabama at Birmingham	RECRUITING
United States	Lafayette Sunwise Clinical Research	RECRUITING
United States	Orange Pacific Neuropsychiatric Specialists	RECRUITING
United States	Rancho Cucamonga Prospective Research Innovations Inc	COMPLETED
United States	San Diego University of California San Diego Medical Center	RECRUITING
United States	Santee CMB Clinical Trials	RECRUITING
United States	Sherman Oaks California Neuroscience Research	COMPLETED
United States	Upland Pacific Clinical Research Medical Group	RECRUITING
United States	West Covina Next Level Clinical Trials, LLC	RECRUITING
United States	Colorado Springs MCB Clinical Research Centers LLC	RECRUITING
United States	Coral Springs CNS Clinical Research Group	RECRUITING
United States	Maitland K2 Medical Research	RECRUITING
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 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	Orlando APG Research LLC	COMPLETED
United States	Orlando Combined Research Orlando	RECRUITING
United States	Pompano Beach Quantum Laboratories	RECRUITING
United States	Port Saint Lucie CDC Research Institute LLC	RECRUITING
United States	Skokie Psychiatric Medicine Associates	RECRUITING
United States	Marrero Tandem Clinical Research	RECRUITING
United States	Gaithersburg CBH Health	RECRUITING
United States	Ann Arbor Michigan Clinical Research Institute	RECRUITING
United States	Farmington Hills Revive Research Institute	RECRUITING
United States	Saint Charles Midwest Research Group	RECRUITING
United States	Lincoln Premier Psychiatric Research Institute, LLC	RECRUITING
United States	Buffalo Erie County Medical Center	COMPLETED
United States	New York Manhattan Behavioral Medicine	RECRUITING
United States	Charlotte New Hope Clinical Research	RECRUITING
United States	Monroe Monroe Biomedical Research	COMPLETED
United States	Columbus Wexner Medical Center at the Ohio State University	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	Moosic Global Medical Institutes	RECRUITING
United States	Austin Donald J Garcia Jr MD PA	RECRUITING
United States	Dallas Relaro Medical Trials	RECRUITING
United States	Dallas UT Southwestern Medical Center	RECRUITING
United States	Stafford R and H Clinical Research	RECRUITING
United States	Murray Cedar Psychiatry	RECRUITING
United States	Bellevue Northwest Clinical Research Center	RECRUITING
United States	Everett Core Clinical Research	COMPLETED
Argentina	Ciudad Autonoma de Buenos Aires Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales	RECRUITING
Argentina	Cordoba CEN Consultorios Especializados en Neurociencias	RECRUITING
Argentina	Cordoba Instituto Medico DAMIC	RECRUITING
Argentina	Cordoba Centro Medico Luquez	RECRUITING
Argentina	La Plata INSA Instituto de Neurociencias San Agustín	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	San Miguel de Tucuman Clinica Mayo de UMCB	RECRUITING
Argentina	Santiago del Estero Clinica El Jardin	RECRUITING
Brazil	Curitiba Trial Tech Tecnologia em Pesquisas com Medicamentos	RECRUITING
Brazil	Porto Alegre Associacao Hospitalar Moinhos de Vento	RECRUITING
Brazil	São Bernardo do Campo CEMEC - Centro Multidisciplinar de Estudos Clínicos	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	Sofia Medical Center Intermedica, OOD	RECRUITING
Bulgaria	Varna Diagnostic Consulting Center Mladost - M Varna	RECRUITING
Canada	Quebec Alpha Recherche Clinique	RECRUITING
China	Baoding Hebei Mental Health Center	RECRUITING
China	Beijing Beijing Anding Hospital of Capital Medical University	RECRUITING
China	Beijing Beijing Huilongguan Hospital	RECRUITING
China	Beijing Peking University Sixth Hospital	RECRUITING
China	Changsha The second Xiangya Hospital of Central South University	RECRUITING
China	Chengdu West China Hospital Sichuan University	RECRUITING
China	Guangzhou Guangdong Provincial People's Hospital	RECRUITING
China	Hu Zhou Huzhou third people's Hospital	RECRUITING
China	Shanghai Shanghai Mental Health Center	RECRUITING
China	Shanghai Tongji Hospital of Tongji University	RECRUITING
China	Shijiazhuang The First Hospital of Hebei Medical University	RECRUITING
China	Tianjin Tianjin Anding Hospital	RECRUITING
China	Wuhan Wuhan Mental Health Center	RECRUITING
China	XI An XiAn Mental Healthcare Center	RECRUITING
Czechia	Brno Psychiatricka ambulance, MUDr. Marta Holanova	COMPLETED
Czechia	Kutna Hora Neuroterapie KH s r o	RECRUITING
Czechia	Praha 6 Medical Services Prague s.r.o.	RECRUITING
Czechia	Praha 8 Institut Neuropsychiatricke pece	RECRUITING
France	Bohars CHU de Brest - Hopital de la Cavale Blanche	RECRUITING
France	Clermont Ferrand CHU Clermont-Ferrand - Hopital Gabriel Montpied	RECRUITING
France	Douai Cabinet Medical des Drs Prizac-Desbonnet Scottez	RECRUITING
France	Nantes CHU de Nantes hotel Dieu	RECRUITING
France	Paris Hopital Sainte Anne	RECRUITING
France	Tours cedex 9 CHRU de Tours Clinique Psychiatrique Universitaire	RECRUITING
South Korea	Bucheon-si Bucheon St. Mary's Hospital	RECRUITING
South Korea	Busan Inje University Haeundae Paik Hospital	RECRUITING
South Korea	Gyeonggi-do Korea University Ansan Hospital	RECRUITING
South Korea	Seoul KyungHee University Hospital	RECRUITING
South Korea	Seoul Korea University Anam Hospital	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
South Korea	Seoul The Catholic University of Korea Yeouido St. Mary's Hospital	RECRUITING
South Korea	Seoul Seoul National University Hospital	RECRUITING
Poland	Bydgoszcz Clinsante Osrodek Badan Klinicznych	RECRUITING
Poland	Katowice Centrum Medyczne Care Clinic Katowice	RECRUITING
Poland	Poznan Filip Rybakowski Specjalistyczna Praktyka Lekarska	RECRUITING
Poland	Suchy Las Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda	RECRUITING
Slovakia	Banska Bystrica Psychomed-Svatosavsky, s.r.o.	RECRUITING
Slovakia	Bojnice Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach	RECRUITING
Slovakia	Bratislava Psychiatricka Ambulancia Mentum S.R.O.	RECRUITING
Slovakia	Koshice Epamed sro	RECRUITING
Slovakia	Kosice Univerzitna nemocnica L. Pasteura Kosice	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
Taiwan	Taichung China Medical University Hospital	RECRUITING
Taiwan	Taipei City Taipei Medical University	RECRUITING
Taiwan	Taipei Taipei Veterans General Hospital	RECRUITING
Taiwan	Taipei Cheng Hsin General Hospital	RECRUITING
United Kingdom	Brighton University of Sussex	RECRUITING
United Kingdom	London Institute of Psychiatry	RECRUITING
United Kingdom	Paisley Renfrewshire CMHT	RECRUITING
United Kingdom	Southampton Moorgreen Hospital	RECRUITING
United States	Gainesville Sarkis Clinical Trials	COMPLETED
Canada	Sherbrooke DIEX Recherche Sherbrooke Inc	COMPLETED
China	Zheng Zhou The First Affiliated Hospital of Zhengzhou University	RECRUITING
United Kingdom	Edinburgh Royal Edinburgh Hospital	RECRUITING
United Kingdom	Wigan And Leigh Crisis Resolution and Home Treatment Team	RECRUITING

Geo Locations

33.52066, -86.80249

37.88576, -122.11802

33.78779, -117.85311

34.1064, -117.59311

32.71533, -117.15726

32.83838, -116.97392

34.15112, -118.44925

34.09751, -117.64839

34.06862, -117.93895

38.83388, -104.82136

26.27119, -80.2706

28.62778, -81.36312

25.77427, -80.19366

25.84621, -80.15394

28.53834, -81.37924

26.23786, -80.12477

27.29393, -80.35033

42.03336, -87.73339

29.89937, -90.10035

39.14344, -77.20137

42.27756, -83.74088

42.48531, -83.37716

38.78394, -90.48123

40.8, -96.66696

42.88645, -78.87837

40.71427, -74.00597

35.22709, -80.84313

34.98543, -80.54951

39.96118, -82.99879

35.65283, -97.4781

35.46756, -97.51643

40.60843, -75.49018

41.35341, -75.73825

30.26715, -97.74306

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29.61607, -95.55772

40.66689, -111.88799

47.61038, -122.20068

47.97898, -122.20208

-34.61315, -58.37723

-31.4135, -64.18105

-34.92145, -57.95453

-32.94682, -60.63932

-26.82414, -65.2226

-27.79511, -64.26149

-25.42778, -49.27306

-30.03306, -51.23

-23.69389, -46.565

42.69751, 23.32415

43.21667, 27.91667

46.81228, -71.21454

38.85111, 115.49028

39.9075, 116.39723

28.19874, 112.97087

30.66667, 104.06667

23.11667, 113.25

30.8643999, 120.107

31.22222, 121.45806

38.04139, 114.47861

39.14222, 117.17667

30.58333, 114.26667

34.2112799, 108.99608

49.19522, 16.60796

49.94839, 15.26816

50.08804, 14.42076

48.42983, -4.51292

45.77966, 3.08628

50.36667, 3.06667

47.21725, -1.55336

48.85341, 2.3488

47.38333, 0.68333

37.49889, 126.78306

35.10278, 129.04028

37.58944, 126.76917

37.566, 126.9784

53.1235, 18.00762

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52.40692, 16.92993

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48.73946, 19.15349

48.78511, 18.5864

48.14816, 17.10674

48.6962603, 21.2285014

48.71395, 21.25808

49.08061, 19.62218

48.38284, 20.02239

48.88836, 21.68479

-33.92584, 18.42322

-25.74486, 28.18783

-34.10687, 18.82751

24.1469, 120.6839

25.04776, 121.53185

50.82838, -0.13947

51.50853, -0.12574

55.83173, -4.43254

50.90395, -1.40428

29.65163, -82.32483

45.40008, -71.89908

34.7457999, 113.645

55.95206, -3.19648

53.5233558, -2.4976583

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

37.88576, -122.11802

33.78779, -117.85311

34.1064, -117.59311

32.71533, -117.15726

32.83838, -116.97392

34.15112, -118.44925

34.09751, -117.64839

34.06862, -117.93895

38.83388, -104.82136

26.27119, -80.2706

28.62778, -81.36312

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

28.53834, -81.37924

28.53834, -81.37924

26.23786, -80.12477

27.29393, -80.35033

42.03336, -87.73339

29.89937, -90.10035

39.14344, -77.20137

42.27756, -83.74088

42.48531, -83.37716

38.78394, -90.48123

40.8, -96.66696

42.88645, -78.87837

40.71427, -74.00597

35.22709, -80.84313

34.98543, -80.54951

39.96118, -82.99879

35.65283, -97.4781

35.46756, -97.51643

35.46756, -97.51643

40.60843, -75.49018

41.35341, -75.73825

30.26715, -97.74306

32.78306, -96.80667

32.78306, -96.80667

29.61607, -95.55772

40.66689, -111.88799

47.61038, -122.20068

47.97898, -122.20208

-34.61315, -58.37723

-31.4135, -64.18105

-31.4135, -64.18105

-31.4135, -64.18105

-34.92145, -57.95453

-34.92145, -57.95453

-32.94682, -60.63932

-26.82414, -65.2226

-27.79511, -64.26149

-25.42778, -49.27306

-30.03306, -51.23

-23.69389, -46.565

42.69751, 23.32415

42.69751, 23.32415

42.69751, 23.32415

42.69751, 23.32415

43.21667, 27.91667

46.81228, -71.21454

38.85111, 115.49028

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723