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



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:September 30, 2015
End Date:October 28, 2017

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An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

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).

This is an open-label (the researchers and participants know the treatment the participant is
receiving), multicenter (more than 1 study site), long-term safety and efficacy study of
intranasal esketamine plus an oral antidepressant in participants with treatment-resistant
depression (TRD). Participants will enter the study either directly (direct-entry
participants) or after completing the Double-Blind Induction Phase of ESKETINTRD3005
(transferred-entry participants). The study consists of 4 phases: Screening Phase (4 weeks),
Open-Label Induction Phase (4 weeks), Open-Label Optimization/Maintenance phase (48 weeks),
and Follow up Phase (4 weeks). Transferred entry non-responders in the ESKETINTRD3005 may
enter study at the Open-Label Induction Phase and responders in the ESKETINTRD3005 may enter
Optimization/Maintenance phase. In the Open-Label Induction Phase, participants will
self-administer flexibly-dosed intranasal esketamine (participants who are less than (<) 65
years old self-administer 56 mg or 84 mg dose, participants who are greater than or equal to
(>=) 65 years old self-administer 28 mg, 56 mg or 84 mg dose) twice weekly for 4 weeks. The
starting dose for all participants >= 65 years old will be 28 mg. In addition, each
direct-entry participants will be assigned to receive 1 of 4 selected oral antidepressant
medications (escitalopram or sertraline or duloxetine or venlafaxine extended release [XR]),
initiated on Day 1 of the open-label induction phase and continued through the duration of
the study. Transferred-entry participants will continue their same antidepressant from
ESKETINTRD3005 through the duration of this study. Participants who are responders at the end
of the Open-Label Induction phase and transferred-entry responder participants (from study
ESKETINTRD3005) will enter the Optimization/Maintenance Phase where intranasal esketamine
treatment sessions will be reduced from that in the induction phase (twice weekly) to weekly
for the first 4 weeks of this phase, and then individualized to either once weekly or once
every other week based on the severity of depressive symptoms. Participants' safety and
depressive symptoms will be assessed and monitored throughout the study.

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
We found this trial at
17
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