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

Phase 1

• Conditions: Treatment-resistant Major Depression; MedDRA version: 18.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-25
• Study Completion: 2017-10-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 802

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 singleepisode
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 taken at adequate
dosage and for adequate duration, as assessed using the Massachusetts General Hospital

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
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 100

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 [ MGH-ATRQ]) -
Participant has a current or prior DSM-5 diagnosis of a psychotic
disorder or MDD with psychosis, bipolar or related disorders (confirmed
by the MINI), comorbid obsessive compulsive disorder, 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 aged greater than or equal to 65 years: 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