Loading
Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 1, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07573176). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Depressive Disorder, Major. Interventions: DRUG: Seltorexant; DRUG: Placebo. Primary outcome measures: Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS) , Baseline up to Day 43; Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs) , OL Baseline (Day 43) Up to 6 months; OL Treatment Phase: Number of Participants with Vital Signs Abnormalities , OL Baseline (Day 43) Up to 6 months; OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS) , OL Baseline (Day 43) Up to 6 months; OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20) , End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days); OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG) , OL Baseline (Day 43) up to 6 months; OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX) , Up to 6 months; OL Treatment Phase: Change from Baseline in the Body Weight , OL Baseline (Day 43) up to 6 months; OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI) , OL Baseline (Day 43) up to 6 months; OL Treatment Phase: Change from Baseline in the Waist Circumference , OL Baseline (Day 43) up to 6 months; OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters , OL Baseline (Day 43) up to 6 months. Brief summary: The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.