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NotableResults posted: Oct 6, 2026Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC · Sponsor's reason: The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025) to The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025) · Eligibility criteria expanded, about 9 words · 2 moreShow 5 more changesShow less
Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
Sponsor's reason: The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025) to The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025)
Eligibility criteria expanded, about 9 words
Secondary endpoints: details revised at 6 of 6 entries
Site details revised at 7 of 234 sites
MinorRe-verified, no change to tracked fieldsv41
NotablePrimary endpoints: 10 to 25Secondary endpoints revised (6)v40Show 1 more changeShow less
StoppedTrial status: Active, Not Recruiting to TerminatedSponsor's reason: The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025)Enrollment target: estimated 840 to confirmed 871 · Study sites: 224 to 234 · Primary completion date changed from estimate of Apr 11, 2025 to Apr 25, 2025 · 1 morev39Show 4 more changesShow less
Enrollment target: estimated 840 to confirmed 871
Study sites: 224 to 234
Primary completion date changed from estimate of Apr 11, 2025 to Apr 25, 2025
Study completion date changed from estimate of Apr 25, 2025 to May 8, 2025
MinorRe-verified, no change to tracked fieldsv38
Show 36 earlier versionsHide 36 earlier versions
MinorStudy sites: 222 to 224v37
MinorTrial status: Recruiting to Active, Not RecruitingPrimary completion date: Oct 22, 2025 to Apr 11, 2025 · Completion date: Dec 15, 2025 to Apr 25, 2025 · Study sites revised (222)v36Show 3 more changesShow less
Primary completion date: Oct 22, 2025 to Apr 11, 2025
MinorStudy sites: 185 to 188Completion date: Oct 22, 2025 to Dec 15, 2025v27Show 1 more changeShow less
Completion date: Oct 22, 2025 to Dec 15, 2025
MinorStudy sites: 179 to 185v26
MinorStudy sites: 169 to 179v25
MinorStudy sites: 163 to 169v24
MinorStudy sites: 150 to 163v23
MinorStudy sites: 143 to 150v22
MinorStudy sites: 123 to 143v21
MinorStudy sites: 107 to 123v20
MinorStudy sites: 98 to 107v19
MinorStudy sites: 84 to 98v18
MinorStudy sites: 68 to 84v17
MinorStudy sites: 60 to 68v16
MinorStudy sites: 53 to 60v15
MinorStudy sites: 42 to 53v14
MinorStudy sites: 38 to 42v13
MinorStudy sites: 28 to 38v12
MinorStudy sites: 24 to 28v11
MinorStudy sites: 20 to 24Completion date: Oct 25, 2025 to Oct 22, 2025v10Show 1 more changeShow less
Completion date: Oct 25, 2025 to Oct 22, 2025
MinorStudy sites: 16 to 20v9
MinorStudy sites: 13 to 16v8
MinorStudy sites: 311 to 13v7
NotablePrimary endpoints: 9 to 10Study sites: 297 to 311 · Completion date: Oct 24, 2025 to Oct 25, 2025 · Secondary endpoints: details revised at 1 of 6 entries · 1 morev6Show 4 more changesShow less
Study sites: 297 to 311
Completion date: Oct 24, 2025 to Oct 25, 2025
Secondary endpoints: details revised at 1 of 6 entries
MinorStudy sites: 272 to 297Completion date: Oct 22, 2025 to Oct 24, 2025v5Show 1 more changeShow less
Completion date: Oct 22, 2025 to Oct 24, 2025
MinorStudy sites: 255 to 272v4
NotableTrial status: Not Yet Recruiting to RecruitingPrimary endpoints revised (9) · Enrollment target: 960 to 840 · Study sites: 157 to 255 · 2 morev3Show 5 more changesShow less
Primary endpoints revised (9)
Enrollment target: 960 to 840
Study sites: 157 to 255
Start date changed from estimate of Sep 9, 2022 to Sep 22, 2022
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).