A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Conditions

• Depressive Disorder, Major

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• Seltorexant — DRUG
  Seltorexant tablet will be administered orally.
• Placebo — DRUG
  Placebo tablet will be administered orally.

Study Details

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.

Key Dates

First listed

May 7, 2026

Start date

Apr 30, 2026

Status verified

Aug 2026

Primary completion

Aug 24, 2028

Completion

May 3, 2029

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Seltorexant
  Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (up to 6 months).
• Placebo Comparator: Placebo
  Participants will receive matching placebo tablet orally once daily from Day 1 to Day 42 in double-blind treatment phase. Eligible participants who will enter the OL treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ EW visit (up to 6 months).

Primary Outcome Measure

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) [ Time Frame: Baseline up to Day 43 ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (31)

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