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

Primary Purpose

Depressive Disorder, Major

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aticaprant
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depressive Disorder, Major, Aticaprant

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 but no more than 3 antidepressants, administered at an adequate dose (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

Sites / Locations

  • University of Alabama at Birmingham - The Kirklin ClinicRecruiting
  • SW Biomedical Research, LLCRecruiting
  • Behavioral Research Specialists, LLCRecruiting
  • Asclepes ResearchRecruiting
  • Excell Research IncRecruiting
  • Prospective Research Innovations, Inc.Recruiting
  • CMB Clinical TrialsRecruiting
  • Viking Clinical Research Ltd.Recruiting
  • Next Level Clinical Trials, LLCRecruiting
  • MCB Clinical Research Centers, LLCRecruiting
  • University of Connecticut Health CenterRecruiting
  • Vertex Research Group, IncRecruiting
  • Sarkis Clinical TrialsRecruiting
  • New Life Medical Research Center, Inc.Recruiting
  • Amedica Research Institute, Inc.Recruiting
  • Galiz ResearchRecruiting
  • Meridian International ResearchRecruiting
  • Global Medical InstitutesRecruiting
  • LCC Medical Research Institute, IncRecruiting
  • Pharmax Research Clinic IncRecruiting
  • Florida Research Center Inc.Recruiting
  • Medical Research Group of Central FloridaRecruiting
  • Chicago Research CenterRecruiting
  • Clinical Trials of AmericaRecruiting
  • Psychiatric Care and Research Center (PCRC)Recruiting
  • Bioscience Research LLCRecruiting
  • Manhattan Behavioral MedicineRecruiting
  • Fieve Clinical Research, Inc.Recruiting
  • Finger Lakes Clinical ResearchRecruiting
  • New Hope Clinical ResearchRecruiting
  • Patient Priority Clinical Sites, LLCRecruiting
  • Wexner Medical Center at the Ohio State UniversityRecruiting
  • Conrad Clinical ResearchRecruiting
  • Suburban Research AssociatesRecruiting
  • University of Pennsylvania - Perelman School of MedicineRecruiting
  • North Texas Clinical TrialsRecruiting
  • Alpine Research OrganizationRecruiting
  • Northwest Clinical Research CenterRecruiting
  • AnimaRecruiting
  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ETRecruiting
  • Ambulatory Group practice for specialized help in psychiary Philipopolis ODDRecruiting
  • Medical Center Mentalcare OODRecruiting
  • Medical Center St. NaumRecruiting
  • MHC - Sofia, EOODRecruiting
  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OODRecruiting
  • Diagnostic Consulting Center Mladost - M VarnaRecruiting
  • Psychiatricka ambulance, MUDr. Marta Holanova
  • Praglandia, s.r.o.Recruiting
  • Clintrial s.r.o.Recruiting
  • NeuropsychiatrieHK, s.r.o.Recruiting
  • Institut Neuropsychiatricke peceRecruiting
  • AUSL LE di LecceRecruiting
  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle ScotteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aticaprant 10 mg

Arm Description

Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of Participants with Adverse Events of Special Interest (AESI)
AEs considered to be of special interest are as Pruritus and Diarrhea.
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Vital signs include body weight, temperature, pulse/heart rate, respiratory rate, pulse oximetry and blood pressure (systolic and diastolic) values.
Number of Participants with Abnormal Body Weight
Participants will be weighed at approximately the same time of day on the same scale, wearing lightweight clothing without shoes; they will be instructed to empty their bladders before being weighed.
Number of Participants with Abnormal Body Mass Index (BMI)
A BMI between 18.5 and 25 kilogram per meter square (kg/m^2) indicates a normal weight.
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. The maximum score assigned for each participant will also be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity.
Number of Participants with Abnormalities in Clinical Laboratory parameters
Number of participants with abnormalities in clinical laboratory parameters will be reported.
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
Withdrawal symptoms are assessed using the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
The ASEX is a participant-reported five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. Total score ranges from 5 to 30, with the higher scores indicating more sexual dysfunction.

Secondary Outcome Measures

Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time
Change from baseline in MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time
Change from baseline in PHQ-9 total score over time will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD) criteria and used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time
Change from baseline in DARS total score over time will be reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD, and particularly to increase scale generalizability while maintaining specificity. Respondents provide their own examples of rewarding experiences across the domains of hobbies, social activities, food/drink, and sensory experience. Participants answer a set of standardized questions about desire, motivation, effort and consummatory pleasure with a recall period of "right now" for the examples provided. The instrument is scored as a total sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia).
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time
Change from baseline in the CGI-S total score over time will be reported. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time
Percentage of participants with >=50% reduction from baseline in the MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Percentage of Participants with Remission of Depressive Symptoms Over Time
Percentage of participants with remission of depressive symptoms over time, defined as a MADRS total score less than or equal to (<=) 10 will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

Full Information

First Posted
August 25, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05518149
Brief Title
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Acronym
VENTURA-LT
Official Title
An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
October 22, 2025 (Anticipated)
Study Completion Date
October 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depressive Disorder, Major, Aticaprant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aticaprant 10 mg
Arm Type
Experimental
Arm Description
Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Aticaprant
Other Intervention Name(s)
JNJ-67953964
Intervention Description
Aticaprant 10 mg tablet will be administered orally.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time Frame
Up to Week 54
Title
Number of Participants with Adverse Events of Special Interest (AESI)
Description
AEs considered to be of special interest are as Pruritus and Diarrhea.
Time Frame
Up to Week 54
Title
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Description
Vital signs include body weight, temperature, pulse/heart rate, respiratory rate, pulse oximetry and blood pressure (systolic and diastolic) values.
Time Frame
Up to Week 54
Title
Number of Participants with Abnormal Body Weight
Description
Participants will be weighed at approximately the same time of day on the same scale, wearing lightweight clothing without shoes; they will be instructed to empty their bladders before being weighed.
Time Frame
Up to Week 54
Title
Number of Participants with Abnormal Body Mass Index (BMI)
Description
A BMI between 18.5 and 25 kilogram per meter square (kg/m^2) indicates a normal weight.
Time Frame
Up to Week 54
Title
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. The maximum score assigned for each participant will also be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity.
Time Frame
Up to Week 54
Title
Number of Participants with Abnormalities in Clinical Laboratory parameters
Description
Number of participants with abnormalities in clinical laboratory parameters will be reported.
Time Frame
Up to Week 54
Title
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Description
Number of participants with abnormalities in ECG will be reported.
Time Frame
Up to Week 54
Title
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
Description
Withdrawal symptoms are assessed using the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
Time Frame
Up to Week 54
Title
Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
Description
The ASEX is a participant-reported five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. Total score ranges from 5 to 30, with the higher scores indicating more sexual dysfunction.
Time Frame
Up to Week 54
Secondary Outcome Measure Information:
Title
Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time
Description
Change from baseline in MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Time Frame
Baseline up to Week 54
Title
Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time
Description
Change from baseline in PHQ-9 total score over time will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD) criteria and used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Time Frame
Baseline up to Week 54
Title
Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time
Description
Change from baseline in DARS total score over time will be reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD, and particularly to increase scale generalizability while maintaining specificity. Respondents provide their own examples of rewarding experiences across the domains of hobbies, social activities, food/drink, and sensory experience. Participants answer a set of standardized questions about desire, motivation, effort and consummatory pleasure with a recall period of "right now" for the examples provided. The instrument is scored as a total sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia).
Time Frame
Baseline up to Week 54
Title
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time
Description
Change from baseline in the CGI-S total score over time will be reported. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Time Frame
Baseline up to Week 54
Title
Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time
Description
Percentage of participants with >=50% reduction from baseline in the MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Time Frame
Week 54
Title
Percentage of Participants with Remission of Depressive Symptoms Over Time
Description
Percentage of participants with remission of depressive symptoms over time, defined as a MADRS total score less than or equal to (<=) 10 will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Time Frame
Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
SW Biomedical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
Asclepes Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Excell Research Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Name
Prospective Research Innovations, Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Name
CMB Clinical Trials
City
Santee
State/Province
California
ZIP/Postal Code
92071
Country
United States
Individual Site Status
Recruiting
Facility Name
Viking Clinical Research Ltd.
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Individual Site Status
Recruiting
Facility Name
Next Level Clinical Trials, LLC
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Individual Site Status
Recruiting
Facility Name
MCB Clinical Research Centers, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Name
Vertex Research Group, Inc
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
New Life Medical Research Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Amedica Research Institute, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Recruiting
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian International Research
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Medical Institutes
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
LCC Medical Research Institute, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmax Research Clinic Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Research Center Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of America
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Individual Site Status
Recruiting
Facility Name
Psychiatric Care and Research Center (PCRC)
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Individual Site Status
Recruiting
Facility Name
Bioscience Research LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Individual Site Status
Recruiting
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Name
Fieve Clinical Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Individual Site Status
Recruiting
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-1609
Country
United States
Individual Site Status
Recruiting
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
Patient Priority Clinical Sites, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Recruiting
Facility Name
Wexner Medical Center at the Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Name
Conrad Clinical Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Recruiting
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania - Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpine Research Organization
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Anima
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
City
Cherven Bryag
ZIP/Postal Code
5980
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Ambulatory Group practice for specialized help in psychiary Philipopolis ODD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Mentalcare OOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center St. Naum
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHC - Sofia, EOOD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic Consulting Center Mladost - M Varna
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Psychiatricka ambulance, MUDr. Marta Holanova
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Individual Site Status
Terminated
Facility Name
Praglandia, s.r.o.
City
Prague 5
ZIP/Postal Code
15000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Clintrial s.r.o.
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
NeuropsychiatrieHK, s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Institut Neuropsychiatricke pece
City
Praha 8
ZIP/Postal Code
186 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
AUSL LE di Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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