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)

March 26, 2024 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability 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

The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

710

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1133AAH
        • Recruiting
        • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
      • Cordoba, Argentina, X5006IKK
        • Recruiting
        • Centro Medico Luquez
      • Cordoba, Argentina, X5003DCE
        • Recruiting
        • Instituto Médico DAMIC
      • Cordoba, Argentina, 5000FJF
        • Recruiting
        • CEN-Consultorios Especializados en Neurociencias
      • La Plata, Argentina, Thanks
        • Recruiting
        • Clinica Privada de Salud Mental Santa Teresa de Avila
      • La Plata, Argentina, 1900
        • Recruiting
        • INSA Instituto de Neurociencias San Agustín
      • Rosario, Argentina, 2000
        • Recruiting
        • C I A P Centro de investigacion y Asistencia en Psiquiatria
      • San Miguel de Tucuman, Argentina, 4000
        • Recruiting
        • Clinica Mayo de UMCB
      • Santiago del Estero, Argentina, 4200
        • Recruiting
        • Clinica El Jardin
  • Bulgaria
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Medical Center Intermedica, OOD
      • Sofia, Bulgaria, 1408
        • Recruiting
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1202
        • Recruiting
        • MHC - Sofia, EOOD
      • Varna, Bulgaria, 9020
        • Recruiting
        • Diagnostic Consulting Center Mladost - M Varna
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Recruiting
        • Diex Recherche Sherbrooke Inc.
  • China
      • Baoding, China, 071000
        • Recruiting
        • Hebei Mental Health Center
      • Beijing, China, 100096
        • Recruiting
        • Beijing HuiLongGuan Hospital
      • Beijing, China, 100088
        • Recruiting
        • Beijing Anding Hospital of Capital Medical University
      • Guangzhou, China, 510060
        • Recruiting
        • Guangdong Provincial People's Hospital
      • Hu Zhou, China, 313000
        • Recruiting
        • Huzhou third people's Hospital
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
      • Tianjin, China, 300222
        • Recruiting
        • Tianjin Anding Hospital
      • Wuhan, China, 430000
        • Recruiting
        • Wuhan Mental Health Center
      • XI An, China, 710061
        • Recruiting
        • XiAn Mental Healthcare Center
  • Czechia
      • Brno, Czechia, 61500
        • Completed
        • Psychiatricka ambulance, MUDr. Marta Holanova
      • Kutna Hora, Czechia, 284 01
        • Recruiting
        • Neuroterapie KH, s.r.o.
      • Praha 6, Czechia, 16000
        • Recruiting
        • Medical Services Prague s.r.o.
      • Praha 8, Czechia, 186 00
        • Recruiting
        • Institut Neuropsychiatricke pece
  • France
      • Bohars, France, 29820
        • Recruiting
        • CHU de Brest - Hôpital de la Cavale Blanche
      • Clermont Ferrand, France, 63000
        • Recruiting
        • CHU Clermont-Ferrand - Hôpital Gabriel Montpied
      • Douai, France, 59500
        • Recruiting
        • Cabinet Medical des Drs Prizac-Desbonnet Scottez
      • Nantes, France, 44093
        • Recruiting
        • CHU de NANTES Hotel Dieu
      • Paris, France, 75674
        • Recruiting
        • Hopital Sainte Anne
      • Tours cedex 9, France, 37044
        • Recruiting
        • CHRU de Tours Clinique Psychiatrique Universitaire
  • Korea, Republic of
      • Bucheon-si, Korea, Republic of, 14647
        • Recruiting
        • Bucheon St. Mary's Hospital
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
      • Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 3080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • KyungHee University Hospital
      • Seoul, Korea, Republic of, 07345
        • Recruiting
        • The Catholic University of Korea Yeouido St. Mary's Hospital
  • Poland
      • Bydgoszcz, Poland, 85-794
        • Recruiting
        • Clinsante Osrodek Badan Klinicznych
      • Katowice, Poland, 40568
        • Recruiting
        • Centrum Medyczne Care Clinic Katowice
      • Poznan, Poland, 60-744
        • Recruiting
        • Filip Rybakowski Specjalistyczna Praktyka Lekarska
      • Suchy Las, Poland, 62-002
        • Recruiting
        • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • Recruiting
        • Psychomed-Svatosavsky, s.r.o.
      • Bojnice, Slovakia, 97201
        • Recruiting
        • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
      • Bratislava, Slovakia, 82007
        • Recruiting
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Koshice, Slovakia, 040 11
        • Recruiting
        • Epamed sro
      • Kosice, Slovakia, 04190
        • Recruiting
        • Univerzitna nemocnica L. Pasteura Kosice
      • Liptovsky Mikulas, Slovakia, 03123
        • Recruiting
        • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
      • Rimavska Sobota, Slovakia, 97901
        • Recruiting
        • Psychiatricka Ambulancia Psycholine s.r.o.
      • Vranov nad Toplou, Slovakia, 9301
        • Recruiting
        • Crystal Comfort s.r.o.
  • South Africa
      • Cape Town, South Africa, 7530
        • Recruiting
        • Cape Town Clinical Research Centre
      • Pretoria, South Africa, 181
        • Recruiting
        • Gert Bosch Pretoria South Africa
      • Strand, South Africa, 7140
        • Recruiting
        • Somerset West Clinical Research Unit
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Recruiting
        • Cheng Hsin General Hospital
      • Taipei City, Taiwan, 110
        • Recruiting
        • Taipei Medical University
  • United Kingdom
      • Paisley, United Kingdom, PA1 1JS
        • Recruiting
        • Renfrewshire CMHT
      • Southampton, United Kingdom, SO30 3JB
        • Recruiting
        • Moorgreen Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Pacific Neuropsychiatric Specialists
      • Rancho Cucamonga, California, United States, 91730
        • Recruiting
        • Prospective Research Innovations Inc
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California San Diego Medical Center
      • Santee, California, United States, 92071
        • Recruiting
        • CMB Clinical Trials
      • Sherman Oaks, California, United States, 91403
        • Completed
        • California Neuroscience Research
      • West Covina, California, United States, 91790
        • Recruiting
        • Next Level Clinical Trials, LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Recruiting
        • MCB Clinical Research Centers, LLC
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Recruiting
        • CNS Clinical Research Group
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Sarkis Clinical Trials
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research
      • Miami, Florida, United States, 33125
        • Recruiting
        • Global Medical Institutes
      • Miami, Florida, United States, 33175
        • Recruiting
        • Ezy Medical Research
      • Miami, Florida, United States, 33126
        • Recruiting
        • LCC Medical Research Institute, Inc
      • Miami, Florida, United States, 33184
        • Recruiting
        • Felicidad Medical Research
      • Miami, Florida, United States, 33122
        • Recruiting
        • Vital Care Research
      • Miami, Florida, United States, 33174
        • Recruiting
        • Florida Research Center Inc.
      • North Bay Village, Florida, United States, 33141
        • Recruiting
        • Bravo Health Care Center
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Combined Research Orlando
      • Orlando, Florida, United States, 32803
        • Completed
        • APG Research LLC
      • Pompano Beach, Florida, United States, 33064
        • Recruiting
        • Quantum Laboratories
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • CDC Research Institute LLC
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Psychiatric Medicine Associates
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • CBH Health
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Michigan Clinical Research Institute
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Revive Research Institute
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Midwest Research Group
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Premier Psychiatric Research Institute, LLC
    • New York
      • Buffalo, New York, United States, 14215
        • Completed
        • Erie County Medical Center
      • New York, New York, United States, 10036
        • Recruiting
        • Manhattan Behavioral Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • New Hope Clinical Research
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Wexner Medical Center at the Ohio State University
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Conrad Clinical Research
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, United States, 73118
        • Recruiting
        • Paradigm Research Professionals, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • LeHigh Center for Clinical Research
      • Moosic, Pennsylvania, United States, 18507
        • Recruiting
        • Global Medical Institutes
    • Texas
      • Austin, Texas, United States, 78737
        • Recruiting
        • Donald J Garcia Jr MD PA
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Relaro Medical Trials
      • Dallas, Texas, United States, 75247-9119
        • Recruiting
        • UT Southwestern Medical Center
      • Stafford, Texas, United States, 77477
        • Recruiting
        • R and H Clinical Research
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Cedar Psychiatry
    • Washington
      • Everett, Washington, United States, 98201
        • Completed
        • Core Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aticaprant
Participants will receive Aticaprant 10 milligrams (mg) tablet orally, once daily for 42 days during double-blind (DB) treatment phase in addition to their current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the DB treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003.
Drug: Aticaprant
Aticaprant tablet will be administered orally.
Other Names:
  • JNJ-67953964
Placebo Comparator: Placebo
Participants will receive matching placebo tablet orally, once daily for 42 days during DB treatment phase in addition to their current antidepressant SSRI/SNRI therapy. Participants who will complete the DB treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003.
Other: Placebo
Placebo tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 43
Time Frame: Baseline to Day 43
Change from baseline in MADRS total score to Day 43 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 possible score of 60. Higher scores represent a more severe condition.
Baseline to Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score to Day 43
Time Frame: Baseline to Day 43
Change from baseline in DARS total score to Day 43 will be reported. DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in major depressive disorder (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 on 0 (not at all) to 4 (very much) and the total score is calculated as a sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia).
Baseline to Day 43
Change From Baseline in MADRS Total Score over Time
Time Frame: Baseline up to Day 57
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 possible score of 60. Higher scores represent a more severe condition.
Baseline up to Day 57
Percentage of Responders on Depressive Symptoms Scale from Baseline to Day 43 as Assessed by MADRS Total Score
Time Frame: Baseline to Day 43
Percentage of responders on depressive symptoms scale, defined as a greater than or equal to (>=) 50 percent (%) improvement in MADRS total score from baseline to Day 43 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 possible score of 60. Higher scores represent a more severe condition.
Baseline to Day 43
Change From Baseline in Patient Health Questionnaire, 9-item (PHQ-9) Total Score to Day 43
Time Frame: Baseline to Day 43
Change from baseline in PHQ-9 total score to Day 43 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) MDD criteria and it is 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.
Baseline to Day 43
Change From Baseline in DARS Total Score Over Time
Time Frame: Baseline up to Day 57
Change from baseline in DARS total score over time will be reported. DARS is a 17-item self-report questionnaire that was 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 on 0 (not at all) to 4 (very much) and the total score is calculated as a sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia).
Baseline up to Day 57
Change from Baseline in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) Over Time
Time Frame: Baseline up to Day 57
Change from baseline in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) over time will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it is 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.
Baseline up to Day 57
Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43
Time Frame: Day 43
Percentage of participants with a score < 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it is 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.
Day 43
Change From Baseline Over Time in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Ability to Participate in Social Roles and Activities 8a (PROMIS-APS 8a)
Time Frame: Baseline up to Day 57
The PROMIS-APS 8a includes items selected from the PROMIS item bank to provide an assessment of the current degree of involvement in one's usual social roles, activities, and responsibilities, including work, family, friends, and leisure. The 8-item short form will be used in this study, and responses to every item are in a 5-point ordinal scale ranging from 1 = "Always" to 5 = "Never," with higher scores indicating better social functioning. The total scores of PROMIS-APS 8a are scaled on a T-score metric with a mean of 50 and a standard deviation (SD) of 10.
Baseline up to Day 57
Percentage of Participants With Remission of Depressive Symptoms at Day 43 as Assessed by MADRS Total Score
Time Frame: Day 43
Percentage of participants with remission of depressive symptoms, defined as a MADRS total score of less than or equal to (<=) 10 at Day 43 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 possible score of 60. Higher scores represent a more severe condition.
Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2022

Primary Completion (Estimated)

October 17, 2024

Study Completion (Estimated)

October 27, 2024

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109230
  • 2022-000461-41 (EudraCT Number)
  • 67953964MDD3002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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