A Phase 3 interventional study of Aticaprant and Placebo in Depressive Disorder, Major and Anhedonia, sponsored by Janssen Research & Development, LLC. Completed at 131 sites in 14 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
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).
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.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's enrollment of 444 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
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
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
Aticaprant tablet will be administered orally.
Also known as: JNJ-67953964
Placebo tablet will be administered orally.
Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
Time frame: Baseline (Day 1) to Day 43
Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score
The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement.
Time frame: Baseline (Day 1) to Day 43
Change From Baseline Over Time in MADRS Total Score
Change from baseline over time in MADRS total score is reported. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
Time frame: Baseline (Day 1), Day 15, Day 29, and Day 43
Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43
Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 are reported. Responders are defined as participants with a \>=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
Time frame: At Day 43
Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43
Percentage of participants with remission of depressive symptoms based on MADRS total score at Day 43 is reported. Participant is defined as a remitter at a given time point if the MADRS total score is less than or equal to (\<=)10 at that time point. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
Time frame: At Day 43
Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score
Change from baseline to Day 43 in PHQ-9 total score is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. 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. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicate improvement.
Time frame: Baseline (Day 1) to Day 43
Change From Baseline Over Time in DARS Total Score
Change from baseline over time in DARS total score is reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement.
Time frame: Baseline (Day 1), Days 15, 29, and 43
Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1)
Change from baseline over time in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. 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. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). PHQ-9, item 1 score ranged from 0-3. Higher score indicates more severe disease. Negative change in PHQ-9, item 1 score indicates improvement.
Time frame: Baseline (Day 1), Day 15, Day 29, and Day 43
Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43
Percentage of participants with a score \<2 in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) at Day 43 is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. 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. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27).
Time frame: At Day 43
Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a)
Change from baseline over time in the PROMIS-APS 8a is reported. This 8-item measure assesses participants' ability to participate in social roles and activities. The items measures the degree of involvement in social roles, activities, and responsibilities, including work, family, friends, and leisure. Each item is rated on a 5-point ordinal scale including 1=always, 2=usually, 3=sometimes, 4=rarely and 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 of 10. PROMIS-APS 8a total score ranges from 8 to 40 and T-score ranges from 25.9 to 65.4, a higher score indicates better social functioning. Positive change in score indicates improvement.
Time frame: Baseline (Day 1), Days 15, 29, and 43
DB Treatment Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Percentage of participants with TEAEs during DB treatment phase are reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE is defined as any AE occurring at or after the initial administration of study intervention through the end of DB phase.
Time frame: From start of treatment (Day 1) up to Day 43
Follow-up (FU) Phase: Percentage of Participants With AEs
Percentage of participants with AEs during FU phase are reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: From Day 44 up to Day 57
| Milestone | Placebo | Aticaprant 10 mg |
|---|---|---|
| Started | 225 | 219 |
| Participants who entered follow-up phase | 21 | 18 |
| Completed | 211 | 209 |
| Not completed | 14 | 10 |
| Withdrew: Withdrawal by subject | 8 | 3 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Other | 0 | 4 |
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
| Units on a scale | Placebo | Aticaprant 10 mg |
|---|---|---|
| Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -9.4 ± 0.96 | -10.0 ± 0.96 |
The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement.
| Units on a scale | Placebo | Aticaprant 10 mg |
|---|---|---|
| Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | 8.2 ± 1.39 | 8.8 ± 1.39 |
Change from baseline over time in MADRS total score is reported. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
| Units on a scale | Placebo | Aticaprant 10 mg |
|---|---|---|
| Day 15 | -4.4 ± 0.75 | -5.4 ± 0.74 |
| Day 29 | -7.5 ± 0.89 | -8.0 ± 0.89 |
| Day 43 | -9.4 ± 0.96 | -10.0 ± 0.96 |
Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 are reported. Responders are defined as participants with a \>=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
| Percentage of participants | Placebo | Aticaprant 10 mg |
|---|---|---|
| Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 | 28.3 | 27.9 |
Percentage of participants with remission of depressive symptoms based on MADRS total score at Day 43 is reported. Participant is defined as a remitter at a given time point if the MADRS total score is less than or equal to (\<=)10 at that time point. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
| Percentage of participants | Placebo | Aticaprant 10 mg |
|---|---|---|
| Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43 | 16.3 | 15.8 |
Change from baseline to Day 43 in PHQ-9 total score is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. 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. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicate improvement.
| Units on a scale | Placebo | Aticaprant 10 mg |
|---|---|---|
| Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score | -5.5 ± 0.58 | -5.2 ± 0.58 |
Change from baseline over time in DARS total score is reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement.
| Units on a scale | Placebo | Aticaprant 10 mg |
|---|---|---|
| Day 15 | 3.5 ± 1.17 | 4.2 ± 1.17 |
| Day 29 | 6.9 ± 1.27 | 7.1 ± 1.27 |
| Day 43 | 8.2 ± 1.39 | 8.8 ± 1.39 |
Change from baseline over time in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. 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. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). PHQ-9, item 1 score ranged from 0-3. Higher score indicates more severe disease. Negative change in PHQ-9, item 1 score indicates improvement.
| Units on a scale | Placebo | Aticaprant 10 mg |
|---|---|---|
| Day 15 | -0.4 ± 0.93 | -0.6 ± 1.08 |
| Day 29 | -0.7 ± 1.00 | -0.8 ± 1.05 |
| Day 43 | -0.9 ± 1.12 | -0.9 ± 1.08 |
Percentage of participants with a score \<2 in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) at Day 43 is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. 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. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27).
| Percentage of participants | Placebo | Aticaprant 10 mg |
|---|---|---|
| Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | 50.8 | 46.3 |
Change from baseline over time in the PROMIS-APS 8a is reported. This 8-item measure assesses participants' ability to participate in social roles and activities. The items measures the degree of involvement in social roles, activities, and responsibilities, including work, family, friends, and leisure. Each item is rated on a 5-point ordinal scale including 1=always, 2=usually, 3=sometimes, 4=rarely and 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 of 10. PROMIS-APS 8a total score ranges from 8 to 40 and T-score ranges from 25.9 to 65.4, a higher score indicates better social functioning. Positive change in score indicates improvement.
| T-score | Placebo | Aticaprant 10 mg |
|---|---|---|
| Day 15 | 1.4 ± 0.54 | 1.5 ± 0.55 |
| Day 29 | 3.2 ± 0.57 | 3.1 ± 0.59 |
| Day 43 | 3.9 ± 0.63 | 4.3 ± 0.64 |
Percentage of participants with TEAEs during DB treatment phase are reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE is defined as any AE occurring at or after the initial administration of study intervention through the end of DB phase.
| Percentage of participants | DB: Placebo | DB: Aticaprant 10 mg |
|---|---|---|
| DB Treatment Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 38.1 | 44.2 |
Percentage of participants with AEs during FU phase are reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
| Percentage of participants | FU: Placebo | FU: Aticaprant 10 mg |
|---|---|---|
| Follow-up (FU) Phase: Percentage of Participants With AEs | 0 | 5.6 |
Collected over All cause mortality: DB treatment phase: From screening (-30 days) up to Day 43, FU Phase: From Day 44 up to Day 57; Serious and Other AEs: DB phase: From Day 1 up to Day 43; FU phase: From Day 44 up to Day 57. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB: Placebo | 0/225 (0%) | 1/223 (0.4%) | 18/223 (8.1%) |
| DB: Aticaprant 10 mg | 0/219 (0%) | 0/217 (0%) | 39/217 (18%) |
| FU: Placebo | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| FU: Aticaprant 10 mg | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Event | DB: Placebo | DB: Aticaprant 10 mg | FU: Placebo | FU: Aticaprant 10 mg |
|---|---|---|---|---|
| AnxietyPsychiatric disorders | 1/223 | 0/217 | 0/21 | 0/18 |
| Event | DB: Placebo | DB: Aticaprant 10 mg | FU: Placebo | FU: Aticaprant 10 mg |
|---|---|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 9/223 | 25/217 | 0/21 | 0/18 |
| DiarrhoeaGastrointestinal disorders | 9/223 | 17/217 | 0/21 | 0/18 |
| Suicidal IdeationPsychiatric disorders | 1/223 | 1/217 | 0/21 | 1/18 |
Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study intervention.
| Age, Continuous(Years) | Placebo | Aticaprant 10 mg | Total |
|---|---|---|---|
| Mean | 49.3 ± 13.11 | 49.1 ± 13.14 | 49.2 ± 13.11 |
| Age, Customized(Participants) | Placebo | Aticaprant 10 mg | Total |
|---|---|---|---|
| Adults (18-64 years) | 200 | 192 | 392 |
| From 65 to 74 years | 23 | 25 | 48 |
| Sex: Female, Male(Participants) | Placebo | Aticaprant 10 mg | Total |
|---|---|---|---|
| Female | 168 | 161 | 329 |
| Male | 55 | 56 | 111 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Aticaprant 10 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 74 | 74 | 148 |
| Not Hispanic or Latino | 141 | 137 | 278 |
| Unknown or Not Reported | 8 | 6 | 14 |
| Race (NIH/OMB)(Participants) | Placebo | Aticaprant 10 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 15 | 16 | 31 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 9 | 9 | 18 |
| White | 182 | 177 | 359 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 13 | 11 | 24 |
| Region of Enrollment(Participants) | Placebo | Aticaprant 10 mg | Total |
|---|---|---|---|
| Argentina | 35 | 37 | 72 |
| Brazil | 8 | 4 | 12 |
| Bulgaria | 9 | 9 | 18 |
| Czech Republic | 11 | 7 | 18 |
| France | 10 | 10 | 20 |
| Poland | 13 | 14 | 27 |
| Slovakia | 19 | 17 | 36 |
| South Africa | 12 | 14 | 26 |
| Korea, Republic of | 9 | 10 | 19 |
| Taiwan | 3 | 2 | 5 |
| United Kingdom | 4 | 5 | 9 |
| United States | 90 | 88 | 178 |
Showing the first 100 of 131 sites across 14 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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
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