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NotableLead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLCPrimary endpoints: details revised at 1 of 1 entry · Trial sites expanded: 39 → 44 locations · Eligibility criteria expanded, about 10 words · 1 moreShow 4 more changesShow less
Primary endpoints: details revised at 1 of 1 entry
Trial sites expanded: 39 → 44 locations
Eligibility criteria expanded, about 10 words
Secondary endpoints: details revised at 13 of 13 entries
MinorTrial sites expanded: 35 → 39 locationsv11
MinorTrial sites expanded: 30 → 35 locationsv10
MinorTrial sites expanded: 27 → 30 locationsv9
MinorTrial sites expanded: 9 → 27 locationsv8
MinorTrial sites expanded: 6 → 9 locationsv7
MinorTrial sites expanded: 2 → 6 locationsv6
MinorRe-verified, no change to tracked fieldsv5
MinorStudy sites: 1 to 2v4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date changed from estimate of Feb 24, 2026 to Jan 8, 2026v3Show 2 more changesShow less
Study sites: 0 to 1
Start date changed from estimate of Feb 24, 2026 to Jan 8, 2026
NotableStart date: Nov 20, 2025 to Feb 24, 2026v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.