A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression

Part of paid clinical trials in Skokie, Illinois.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07716098
Phase
PHASE3
Status
Recruiting
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Conditions

  • Depressive Disorder, Treatment-Resistant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Esketamine 56 mg — DRUG
    Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
  • Esketamine 84 mg — DRUG
    Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
  • Placebo — DRUG
    Participants will self-administer placebo as intranasal spray into each nostril.

Study Details

The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams \[mg\] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \[MDD\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).

Key Dates

First listed
Jul 21, 2026
Start date
Jul 27, 2026
Status verified
Jul 2026
Primary completion
Dec 27, 2028
Completion
Sep 12, 2029

Study Design

Enrollment
348 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Esketamine 56 milligram (mg)
    Participants will be randomized to receive double-blind (DB) treatment with esketamine 56 mg, twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 or 84 mg.
  • Experimental: Esketamine 84 mg
    Participants will be randomized to receive DB treatment with esketamine 84 mg, twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 or 84 mg.
  • Placebo Comparator: Placebo
    Participants will be randomized to receive DB treatment with placebo twice a week for 4 weeks. Participants who complete the DB treatment phase on Day 28 may be eligible to participate in an open-label treatment phase and receive either esketamine 56 mg or 84 mg.

Primary Outcome Measure

Double-Blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Day 1 to the End of the 4-Week Double-Blind Treatment Phase [ Time Frame: Baseline (Day 1 [prerandomization]) up to end of the 4-Week DB treatment phase (Day 28) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Psychiatric Medicine Associates LLCSkokieIllinois60076-
The Medical Research Network, LLCNew YorkNew York10128-

Find similar trials in Skokie, IL

By research site
Psychiatric Medicine Associates LLC· Skokie, ILThe Medical Research Network, LLC· New York, NY

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