Last updated on November 2017

A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Depression (Treatment-Resistant)
  • Gender: Male or Female
  • Other:

    Inclusion Criteria:

    • Subject must meet DSM-5 diagnostic criteria for recurrent MDD, without psychotic features

    • Subject must have had non-response to greater than or equal to 2 but less than 6 antidepressant treatments in the current episode of depression

    • Subject must be medically stable

    • 18 to 64 years of age

    Exclusion Criteria:

    • The subject’s depressive symptoms have previously not responded to esketamine/ketamine or a non-response in the current major depressive episode to all of the oral antidepressant treatment options for the Double-Blind Induction Phase (e.g., duloxetine, escitalopram, sertraline, venlafaxine XR)

    • Currently has VNS or DBS

    • Has a current or prior diagnosis of a psychotic disorder or MDD with
      psychosis, bipolar or related disorders, comorbid obsessive compulsive disorder, intellectual disability; borderline, antisocial, histrionic , or narcissistic personality disorder

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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