A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicide; Suicidal Ideation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram
      (mg) compared with intranasal placebo along with standard care treatment, in reducing the
      symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a
      dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is
      prominent and relatively persistent), including the risk for suicide as assessed by the
      Investigator, in participants who will be assessed to be at imminent risk for suicide.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), double-blind
      (neither physician nor participant knows assigned study treatment), placebo-controlled
      (participants are randomly assigned to a test treatment or to an identical-appearing
      treatment that does not contain the test drug), and multicenter (when more than one hospital
      or medical school team works on a medical research study), study of esketamine in
      participants with major depressive disorder (MDD) in participants who will be assessed to be
      at imminent risk for suicide, as measured by the change from Baseline on the
      Montgomery-Asberg Depression Rating Scale (MADRS) total score at 4 hours postdose on Day 1.
      The duration of study will be approximately 81 days per participant. The study consists of 3
      parts: Screening (that is, with in 1 day before study commences on Day 1) and double-blind
      Treatment (from Day 1-25) and Follow-up (from Day 26 up to Day 81). All the eligible
      participants will be provided standard care treatment and will be randomly assigned to either
      esketmaine or placebo treatment. Esketamine/placebo will be administered by intranasal route
      (delivery of medications through the nasal mucosa) two times per week for 4 weeks. Efficacy
      of the participants will be primarily evaluated through MADRS. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Esketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Esketamine 84 mg will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25). Dose may be reduced to 56 mg per day based on Investigator's discretion.; Matching placebo will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25).
Other intervention name(s): Esketamine hydrochloride
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Esketamine; Intranasal esketamine; Placebo