Clinical Trial Details

A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

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Trial Information

Broad Health Condition Treatment-resistant Depression

Specific Health Condition

Trial FocusTreatment

Recruitment statusCompleted

Phase of TrialPhase 3

Trial summary

The purpose of this open-label, multicenter study is to assess the long term safety and
efficacy of intranasal esketamine plus an oral antidepressant in participants with
treatment-resistant depression (TRD).
Eligibility

Key inclusion criteria

Inclusion Criteria:

  A). For Direct-Entry Participants

    -  At the time of signing the informed consent form (ICF), participant must be a man or
       woman =18 (or older if the minimum legal age of consent in the country in which the
       study is taking place is greater than [>]18)

    -  At the start of the screening phase, participant must meet the Diagnostic and
       Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode
       major depressive disorder (MDD) (if single-episode MDD, the duration must be greater
       than or equal to [>=] 2 years) or recurrent MDD, without psychotic features, based
       upon clinical assessment and confirmed by the Mini-International Neuropsychiatric
       Interview (MINI)

    -  At screening, participant must have a MADRS total score of >=22

    -  At the start of the screening phase, participants must have had nonresponse to >=2
       oral antidepressant treatments in the current episode of depression, as assessed using
       the the MGHATRQ and confirmed by documented records (example
       medical/pharmacy/prescription records or a letter from treating a physician, etc,) B).
       For Transferred-entry Participants

    -  All participants who completed the double-blind induction phase of ESKETINTRD3005
       study, regardless of their response status, will be eligible to participate in this
       study, if they meet the study specific eligibility criteria

  Exclusion Criteria:

  A). For Direct-Entry Participants

    -  Participant's depressive symptoms have previously not responded to: Esketamine or
       ketamine in the current major depressive episode per clinical judgment or All of the 4
       oral antidepressant treatment options available in the respective country for the
       open-label induction phase (that is, duloxetine, escitalopram, sertraline, and
       venlafaxine XR) in the current major depressive episode (based on Massachusetts
       General Hospital - Antidepressant Treatment Response Questionnaire [ MGH-ATRQ])

    -  Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with
       psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive
       compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes
       317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline
       personality disorder, antisocial personality disorder, histrionic personality
       disorder, or narcissistic personality disorder

    -  Participant has homicidal ideation/intent, per the investigator's clinical judgment,
       or has suicidal ideation with some intent to act within 6 months prior to the start of
       the screening phase, per the investigator's clinical judgment or based on the Columbia
       Suicide Severity Rating Scale (C-SSRS)

    -  Participants with history of moderate or severe substance or alcohol use disorder
       according to DSM-5 criteria

    -  Participants who has a Mini Mental State Examination (MMSE) <25; Has neurodegenerative
       disorder (example, Alzheimer's disease, vascular dementia, Parkinson's disease), or
       evidence of mild cognitive impairment (MCI) B). Transferred-Entry Participants

    -  Participant has taken any prohibited therapies that would not permit dosing on Day 1

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Janssen Research & Development, LLC

Trial websitehttps://clinicaltrials.gov/show/NCT02497287

Trial IDNCT02497287