A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Janssen Research & Development, LLC
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single episode MDD, the duration of the episode must be greater than or equal to \[\>=\] 12 months) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview (MINI) as the primary diagnosis. Participant must have had the first onset of depression prior to 55 years of age * Participant must have had nonresponse (l…
Interventions
- DrugEsketamine 56 mg
Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
- DrugEsketamine 84 mg
Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
- DrugPlacebo
Participants will self-administer placebo as intranasal spray into each nostril.
Locations (15)
- Anderson Clinical ResearchRedlands, California
- Psychiatric Medicine Associates LLCSkokie, Illinois
- The Medical Research Network, LLCNew York, New York
- Kishiro Mental ClinicKawasaki
- Tatsuta ClinicKobe
- National Center of Neurology and PsychiatryKodaira-shi