A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disord

A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant (VENTURA-7)

Last Updated March 5, 2025

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67953964MDD3007

OVERVIEW

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

3
Sites
82 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

CONDITIONS

Depressive Disorder, Major
Anhedonia

ELIGIBILITY

Inclusion Criteria:

* Be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and double blind (DB) 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 (DSM-5 296.22, 296.23, 296.32, or 296.33), based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 axis I disorders-clinical trials version (SCID-CT)
* Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to MDE module symptom Item 2) on the SCID-CT at screening
* Have had an inadequate response to at least 1 and up to 5 (inclusive) oral antidepressant treatments, administered at an adequate dose
* Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI) antidepressants at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, or 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

Exclusion Criteria:

* Has had no response (treatment failure) to 2 or more consecutive antidepressant treatments administered at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current episode of depression including the current SSRI/SNRI (that is the one to be continued in the treatment phases) assessed using the MGH ATRQ
* Has one or more of the following diagnoses: (1) a current or prior (lifetime) DSM-5 diagnosis of: (a) a psychotic disorder or MDD with psychotic features, (b) bipolar or related disorders, (c) intellectual disability, (d) autism spectrum disorder, (e) borderline personality disorder, (f) antisocial personality disorder, (g) histrionic personality disorder, (h) narcissistic personality disorders, (i) somatoform disorders; (2) A primary DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of: (a) panic disorder, (b) generalized anxiety disorder, (c) social anxiety disorder, (d) specific phobia; (3) A current (in the past year) DSM-5 diagnosis of: (a) obsessive-compulsive disorder, (b) post-traumatic stress disorder, (c) anorexia nervosa, (d) bulimia nervosa
* 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 in the current depressive episode had vagal nerve stimulation or deep brain stimulation device in the current episode or has had an inadequate response to an adequate course of intravenous or intranasal ketamine or esketamine (greater than [>] 2 treatments), or electroconvulsive therapy (that is at least 7 treatments)
* Has 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 suicidality 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) for suicidal ideation on the C-SSRS, 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 DB baseline should be excluded

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Belgium, Brazil, Bulgaria, Finland, Hungary, Poland, Spain, Sweden

Country (9)	City or Province (82)	Status
United States	Peachtree Corners Accelerated Clinical Trials LLC	RECRUITING
United States	Brooklyn Integrative Clinical Trials LLC	RECRUITING
United States	Houston Brain Health Consultants	RECRUITING
United States	Houston Red Oak Psychiatry Associates	RECRUITING
United States	Huntsville UAB Huntsville Regional Medical Campus	RECRUITING
United States	Phoenix IMA Clinical Research PC	RECRUITING
United States	Tucson Noble Clinical Research	RECRUITING
United States	Anaheim Advanced Research Center Inc	RECRUITING
United States	Bellflower CI Trials	RECRUITING
United States	Glendale Behavioral Research Specialists LLC	RECRUITING
United States	Imperial Sun Valley Research Center	RECRUITING
United States	Orange ATP Clinical Research	RECRUITING
United States	San Jose Lumos Clinical Research Center LLC	RECRUITING
United States	Temecula Viking Clinical Research Ltd	RECRUITING
United States	Walnut Creek Sunwise Clinical Research	RECRUITING
United States	Colorado Springs MCB Clinical Research Centers LLC	RECRUITING
United States	Aventura Humanity Clinical Research Corp	RECRUITING
United States	Boca Raton Elligo Independent Research Sites Mindful Behavioral Health	RECRUITING
United States	Fort Myers Gulfcoast Medical Research Center	RECRUITING
United States	Hialeah New Life Medical Research Center, Inc.	RECRUITING
United States	Miami Lakes Medquest Translational Sciences	RECRUITING
United States	Miami LCC Medical Research Institute Inc	RECRUITING
United States	Miami Floridian Clinical Research LLC	RECRUITING
United States	Pembroke Pines Best Choice Medical and Research Service	RECRUITING
United States	Tampa K2 Medical Research	RECRUITING
United States	West Palm Beach Neuroscience Research Institute	RECRUITING
United States	Springfield Southern Illinois University School of Medicine	RECRUITING
United States	New Orleans DelRicht Research	RECRUITING
United States	Gaithersburg CBH Health	RECRUITING
United States	New York Fieve Clinical Research Inc	RECRUITING
United States	Charlotte New Hope Clinical Research	RECRUITING
United States	Cincinnati Patient Priority Clinical Sites LLC	RECRUITING
United States	Columbus OSU Department of Psychiatry and Behavioral Health	RECRUITING
United States	Edmond Conrad Clinical Research	RECRUITING
United States	Media Suburban Research Associates	RECRUITING
United States	Houston UTHealth Houston Center for Interventional Psychiatry	RECRUITING
United States	Richmond Perceptive Pharma Research	RECRUITING
United States	Sherman Revival Research Institute LLC	RECRUITING
United States	Bellevue Northwest Clinical Research Center	RECRUITING
Belgium	Alken Anima	RECRUITING
Belgium	La Louvière Chu Tivoli	RECRUITING
Belgium	Liege Centre Hospitalier Specialise Notre Dame Des Anges Asbl	RECRUITING
Belgium	Mechelen Meclinas	RECRUITING
Brazil	Sao Bernardo do Campo Centro Integrado Facili	RECRUITING
Brazil	Sao Paulo BR Trials	RECRUITING
Bulgaria	Bourgas Mental Health Center Prof. Dr. Ivan Temkov	RECRUITING
Bulgaria	Plovdiv Medical Center Mentalcare OOD	RECRUITING
Bulgaria	Sofia MHC - Sofia, EOOD	RECRUITING
Bulgaria	Sofia Centre for Mental Health Prof.N.Shipkovenski EOOD	RECRUITING
Finland	Helsinki Terveystalo Ruoholahti	RECRUITING
Finland	Kuopio Savon Psykiatripalvelu	RECRUITING
Finland	Oulu Northern Clinical Trial Coordinators	RECRUITING
Finland	Oulu Oulu Mentalcare Oy	RECRUITING
Finland	Tampere Mehilainen Finlayson	RECRUITING
Finland	Turku Clinical Research Services Turku - CRST	RECRUITING
Hungary	Budapest Semmelweis Egyetem	RECRUITING
Hungary	Budapest Eszak Budai Szent Janos Centrumkorhaz	RECRUITING
Hungary	Budapest Processus Kft	RECRUITING
Hungary	Gyongyos Bugat Pal Korhaz	RECRUITING
Hungary	Gyor Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz	RECRUITING
Hungary	Kalocsa Dr Mathe es Tarsa Bt	RECRUITING
Hungary	Pecs Pte Aok Pszichiatriai Klinika	RECRUITING
Hungary	Pecs PsychoTech Kft	RECRUITING
Hungary	Szekszard Tolna Varmegyei Balassa Janos Korhaz	RECRUITING
Poland	Bydgoszcz Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska	RECRUITING
Poland	Gdansk Centrum Zdrowia Alcea	RECRUITING
Poland	Gdansk Centrum Badan Klinicznych PI House sp z o o	RECRUITING
Poland	Torun Osrodek Badan Klinicznych CLINSANTE S C	RECRUITING
Poland	Wroclaw Ginemedica Sp. z o.o.	RECRUITING
Spain	Barcelona Hosp. de La Santa Creu I Sant Pau	RECRUITING
Spain	Barcelona Institucion Hosp Hestia Palau	RECRUITING
Spain	Madrid Hospital Ramon y Cajal	RECRUITING
Spain	Oviedo Centro Salud Mental La Corredoria	RECRUITING
Spain	Sabadell Corporacio Sanitari Parc Tauli	RECRUITING
Spain	Sevilla Hosp. Virgen Del Rocio	RECRUITING
Spain	Vigo Hosp. Alvaro Cunqueiro	RECRUITING
Spain	Zamora Hosp. Prov. de Zamora	RECRUITING
Sweden	Halmstad Affecta Pskyiatrimottagning	RECRUITING
Sweden	Linkoping Linkoping University Hospital	RECRUITING
Sweden	Lund ProbarE i Lund AB	RECRUITING
Sweden	Stockholm ProbarE i Stockholm AB	RECRUITING
Sweden	Stockholm Studieenheten Akademiskt Specialistcentrum Stockholm	RECRUITING

Geo Locations

33.9701, -84.22159

40.6501, -73.94958

29.76328, -95.36327

34.7304, -86.58594

33.44838, -112.07404

32.22174, -110.92648

33.83529, -117.9145

33.88168, -118.11701

34.14251, -118.25508

32.84755, -115.56944

33.78779, -117.85311

37.33939, -121.89496

33.49364, -117.14836

37.90631, -122.06496

38.83388, -104.82136

25.95648, -80.13921

26.3669, -80.13033

26.62168, -81.84059

25.8576, -80.27811

25.90871, -80.30866

25.77427, -80.19366

26.00315, -80.22394

27.94752, -82.45843

26.71534, -80.05337

39.80172, -89.64371

29.95465, -90.07507

39.14344, -77.20137

40.71427, -74.00597

35.22709, -80.84313

39.12713, -84.51435

39.96118, -82.99879

35.65283, -97.4781

39.91678, -75.38769

29.76328, -95.36327

29.58218, -95.76078

33.63566, -96.60888

47.61038, -122.20068

50.87553, 5.30558

50.48657, 4.18785

50.63373, 5.56749

51.02574, 4.47762

-23.69389, -46.565

-23.5475, -46.63611

42.50606, 27.46781

42.15, 24.75

42.69751, 23.32415

60.16952, 24.93545

62.89238, 27.67703

65.01236, 25.46816

61.49911, 23.78712

60.45148, 22.26869

47.49801, 19.03991

47.78257, 19.928

47.68333, 17.63512

46.52639, 18.98583

46.08333, 18.23333

46.35014, 18.70905

53.1235, 18.00762

54.35205, 18.64637

53.01375, 18.59814

51.1, 17.03333

41.38879, 2.15899

40.4165, -3.70256

43.36029, -5.84476

41.54329, 2.10942

37.38283, -5.97317

42.23282, -8.72264

41.50633, -5.74456

56.67446, 12.85676

58.41086, 15.62157

55.70584, 13.19321

59.33258, 18.0649

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

33.9701, -84.22159

40.6501, -73.94958

29.76328, -95.36327

29.76328, -95.36327

34.7304, -86.58594

33.44838, -112.07404

32.22174, -110.92648

33.83529, -117.9145

33.88168, -118.11701

34.14251, -118.25508

32.84755, -115.56944

33.78779, -117.85311

37.33939, -121.89496

33.49364, -117.14836

37.90631, -122.06496

38.83388, -104.82136

25.95648, -80.13921

26.3669, -80.13033

26.62168, -81.84059

25.8576, -80.27811

25.90871, -80.30866

25.77427, -80.19366

25.77427, -80.19366

26.00315, -80.22394

27.94752, -82.45843

26.71534, -80.05337

39.80172, -89.64371

29.95465, -90.07507

39.14344, -77.20137

40.71427, -74.00597

35.22709, -80.84313

39.12713, -84.51435

39.96118, -82.99879

35.65283, -97.4781

39.91678, -75.38769

29.76328, -95.36327

29.58218, -95.76078

33.63566, -96.60888

47.61038, -122.20068

50.87553, 5.30558

50.48657, 4.18785

50.63373, 5.56749

51.02574, 4.47762

-23.69389, -46.565

-23.5475, -46.63611

42.50606, 27.46781

42.15, 24.75

42.69751, 23.32415

42.69751, 23.32415

60.16952, 24.93545

62.89238, 27.67703

65.01236, 25.46816

65.01236, 25.46816

61.49911, 23.78712

60.45148, 22.26869

47.49801, 19.03991

47.49801, 19.03991

47.49801, 19.03991

47.78257, 19.928

47.68333, 17.63512

46.52639, 18.98583

46.08333, 18.23333

46.08333, 18.23333

46.35014, 18.70905

53.1235, 18.00762

54.35205, 18.64637

54.35205, 18.64637

53.01375, 18.59814

51.1, 17.03333