Trial · NCT05455684
A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
NCT05455684, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2025-11-06
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy. Trials, record NCT05455684. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05455684
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
- NCT number
- NCT05455684
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 513 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Depressive Disorder, Major, Anhedonia
- Interventions
- Aticaprant, Placebo
- First posted
- 2022-07-13
- Last updated
- 2025-11-06
- Other registries' IDs
- eudract:2022-000439-22
- Results first posted
- 2025-11-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline (Day 1) to Day 43 | 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. |
| Secondary | Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | Baseline (Day 1) to Day 43 | 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 (ranges from 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement. |
| Secondary | Change From Baseline Over Time in MADRS Total Score | Baseline (Day 1), Days 15, 29 and 43 | 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. |
| Secondary | Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 | 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. |
| Secondary | Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43 | 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. |
| Secondary | Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score | Baseline (Day 1) to Day 43 | 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. |
| Secondary | Change From Baseline Over Time in DARS Total Score | Baseline (Day 1), Days 15, 29, and 43 | 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. |
| Secondary | Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) | Baseline (Day 1), Day 15, Day 29, and Day 43 | 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). Negative changes in PHQ-9 total score indicate improvement. |
| Secondary | Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | 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). |
| Secondary | 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) | Baseline (Day 1), Days 15, 29, and 43 | 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 ranges from 8 to 40 and is transformed using a T-score metric with a mean of 50 and a standard deviation of 10. T-score ranges from 25.9 to 65.4, a higher score indicates better social functioning. Positive change in score indicates improvement. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline (Day 1) to Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | Baseline (Day 1) to Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in MADRS Total Score | Baseline (Day 1), Days 15, 29 and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 | At Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43 | At Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score | Baseline (Day 1) to Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in DARS Total Score | Baseline (Day 1), Days 15, 29, and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) | Baseline (Day 1), Day 15, Day 29, and Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | At Day 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | 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) | Baseline (Day 1), Days 15, 29, and 43 | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | T-score | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Placebo | -11.4 | Standard Error 0.98 | Units on a scale | |
| Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Aticaprant 10 mg | -12.3 | Standard Error 0.95 | Units on a scale | |
| Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | Placebo | 10.5 | Standard Error 1.50 | Units on a scale | |
| Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | Aticaprant 10 mg | 12.0 | Standard Error 1.43 | Units on a scale | |
| Change From Baseline Over Time in MADRS Total Score | Placebo | At Day 15 | -5.4 | Standard Error 0.76 | Units on a scale |
| Change From Baseline Over Time in MADRS Total Score | Aticaprant 10 mg | At Day 15 | -6.6 | Standard Error 0.72 | Units on a scale |
| Change From Baseline Over Time in MADRS Total Score | Placebo | At Day 29 | -9.4 | Standard Error 0.90 | Units on a scale |
| Change From Baseline Over Time in MADRS Total Score | Aticaprant 10 mg | At Day 29 | -11.1 | Standard Error 0.87 | Units on a scale |
| Change From Baseline Over Time in MADRS Total Score | Placebo | At Day 43 | -11.4 | Standard Error 0.98 | Units on a scale |
| Change From Baseline Over Time in MADRS Total Score | Aticaprant 10 mg | At Day 43 | -12.3 | Standard Error 0.95 | Units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 259 | |
| Overall Study | STARTED | Aticaprant 10 mg | 254 | |
| Overall Study | Safety Analysis Set | Placebo | 258 | |
| Overall Study | Safety Analysis Set | Aticaprant 10 mg | 253 | |
| Overall Study | Participants Who Entered Follow-up Phase | Placebo | 24 | |
| Overall Study | Participants Who Entered Follow-up Phase | Aticaprant 10 mg | 14 | |
| Overall Study | COMPLETED | Placebo | 244 | |
| Overall Study | COMPLETED | Aticaprant 10 mg | 240 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Aticaprant 10 mg | 14 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | DB: Placebo | 8 | 258 | |
| other | Diarrhoea | Gastrointestinal disorders | DB: Aticaprant 10 mg | 14 | 253 | |
| other | Diarrhoea | Gastrointestinal disorders | FU: Placebo | 0 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | FU: Aticaprant | 0 | 14 | |
| other | Nasopharyngitis | Infections and infestations | DB: Placebo | 6 | 258 | |
| other | Nasopharyngitis | Infections and infestations | DB: Aticaprant 10 mg | 4 | 253 | |
| other | Nasopharyngitis | Infections and infestations | FU: Placebo | 0 | 24 | |
| other | Nasopharyngitis | Infections and infestations | FU: Aticaprant | 1 | 14 | |
| other | Headache | Nervous system disorders | DB: Placebo | 22 | 258 | |
| other | Headache | Nervous system disorders | DB: Aticaprant 10 mg | 17 | 253 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB: Placebo | 0 | 258 |
| Total, all-cause mortality | DB: Aticaprant 10 mg | 0 | 253 |
| Total, all-cause mortality | FU: Placebo | 0 | 24 |
| Total, all-cause mortality | FU: Aticaprant | 0 | 14 |
| Total, other adverse events | DB: Placebo | 34 | 258 |
| Total, other adverse events | DB: Aticaprant 10 mg | 54 | 253 |
| Total, other adverse events | FU: Placebo | 0 | 24 |
| Total, other adverse events | FU: Aticaprant | 1 | 14 |
| Total, serious adverse events | DB: Placebo | 1 | 258 |
| Total, serious adverse events | DB: Aticaprant 10 mg | 3 | 253 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT05455684/results?page=2