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

Phase 1

• Conditions: Treatment-resistant Major Depression; MedDRA version: 18.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-004587-38-BE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-13
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 877

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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 127

Exclusion Criteria

Exclusion Criteria:
A). For Direct-Entry Participants
- Participant’s depressive symptoms have previously not responded to: 1).Esketamine or ketamine in the current major depressive episode per clinical judgment,
2). 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 [ MGHATRQ])
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified