Trial · NCT06514742
A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant
NCT06514742, Phase 3, Terminated, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant. Trials, record NCT06514742. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06514742
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant
- NCT number
- NCT06514742
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 101 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Depressive Disorder, Major, Anhedonia
- Interventions
- Aticaprant, Placebo
- First posted
- 2024-07-23
- Last updated
- 2026-02-17
Source ClinicalTrials.gov
Registered outcomes10
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 Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Day 43 | Change from baseline to Day 43 in MADRS total score will be reported. |
| Secondary | Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | Baseline to Day 43 | Change from baseline to Day 43 in DARS total score will be reported. |
| Secondary | Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score | Baseline to Day 43 | Change from baseline to Day 43 in CSFQ-14 total score will be reported. |
| Secondary | Change From Baseline Over Time in MADRS Total Score | For double-blind (DB) treatment phase: Baseline (Day 1), Up to Day 43; For open-label (OL) treatment phase: Baseline (Day 43), Up to Week 31 | Change from baseline over time in the MADRS total score will be reported. |
| Secondary | 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 | Baseline to Day 43 | Percentage of responders on depressive symptoms scale, defined as a \>= 50 % improvement in MADRS total score from baseline to Day 43 will be reported. |
| Secondary | Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43 | Day 43 | Percentage of participants with remission of depressive symptoms, defined as a MADRS total score \<=10 at Day 43 will be reported. |
| Secondary | Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score | Baseline to Day 43 | Change from baseline to Day 43 in the PHQ-9 total score will be reported. |
| Secondary | Change From Baseline Over Time in DARS Total score. | For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31 | Change from baseline over time in DARS total score will be reported. |
| Secondary | Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1). | For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31 | Change from baseline over time in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) will be reported. |
| Secondary | Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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.
GET https://conductscience.org/api/trials/v1/NCT06514742
GET https://conductscience.org/api/trials/v1/NCT06514742/registered