A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
Condition: Treatment Resistant Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and dose response of intranasal
      esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with
      placebo in improving depressive symptoms in participants with treatment-resistant depression
      (TRD).
    

Detailed description: 
      This will be a 2-panel, randomized ( participants are assigned different treatments based on
      chance), double-blind (neither investigator nor participant knows which treatment the
      participant receives), placebo-controlled (placebo is an inactive substance that is compared
      with a drug to test whether the drug has a real effect in a clinical trial), multicenter
      study. Approximately 100 male and female adult participants diagnosed with TRD will
      participate in this study. For participants in both panels (Panel A and Panel B), there will
      be 4 study phases: a 4-week screening phase, a double-blind treatment phase (Day 1 to Day
      15), an optional open-label treatment phase (Panel A: Day 15 to 74; Panel B: Day 15 to 25),
      and an 8-week post-treatment (follow-up) phase. Depending on the treatment Panel, patients
      will be assigned to intranasal placebo or intranasal esketamine 14 mg, 28 mg, 56 mg, or 84
      mg. Safety assessments will be performed throughout the study. The maximum study duration for
      a participant will be 23 weeks for Panel A and 16 weeks for Panel B.
    

Intervention name(s): Esketamine 14 mg; Esketamine 28 mg; Esketamine 56 mg; Esketamine 84 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 to 6 sprays of esketamine 14 mg self-administered as an intranasal formulation for 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable during the optional open-label phase for up to 4 days; 1 to 6 sprays of esketamine 28 mg self-administered as an intranasal formulation for 4 days (Days 1,4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days; 1 to 6 sprays of esketamine 56 mg self-administered as an intranasal formulation for up to 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days; 1 to 6 sprays of esketamine 84 mg self-administered as an intranasal formulation for up to 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days; 1 to 6 sprays of placebo self-administered as an intranasal formulation for 2 days (Days 1 and 4) or depending on response on Day 8, for 4 days (Days 1,4, 8, 11) during the double-blind phase
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment resistant depressive disorder; Intranasal esketamine; Efficacy; SYNAPSE; JNJ-54135419