Overview

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Status:
Withdrawn
Trial end date:
2021-07-25
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression (TRD) who have failed at least 2 (and no more than 6) prior antidepressant (AD) treatments in the current moderate to severe depressive episode with flexibly-dosed esketamine nasal spray plus a newly initiated oral standard-of-care AD compared with placebo nasal spray plus a newly-initiated standard-of-care oral AD, in achieving remission and staying relapse-free after remission.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag International NV
Treatments:
Antidepressive Agents
Bupropion
Citalopram
Dexetimide
Duloxetine Hydrochloride
Esketamine
Mianserin
Mirtazapine
S 20098
Sertraline
Trazodone
Criteria
Inclusion Criteria:

- At screening, each participant must meet Diagnostic and Statistical Manual of Mental
Disorders, fifth edition (DSM-5) diagnostic criteria for single episode major
depressive disorder (MDD) or recurrent MDD, without psychotic features, based on
clinical assessment and confirmed by the Mini International Neuropsychiatric Interview
(MINI)

- At baseline, each participant must have an Inventory of Depressive Symptomology
Clinician-Rated 30 Items Scale (IDS-C30) total score of greater than or equal to (>= )
34

- At screening, participants must have had a documented nonresponse to at least 2 but
not more than 6 oral antidepressants (AD) treatments taken at adequate dosage and for
adequate duration within the current episode of depression evaluated retrospectively.
Nonresponse documentation at screening must include the sequence of retrospectively
failed antidepressants and combination and or augmentation for retrospectively failed
antidepressants

- Must be medically stable based on physical examination, medical history, vital signs
(including blood pressure). If there are any abnormalities that are not specified in
the inclusion and exclusion criteria, their clinical significance must be determined
by the investigator and recorded in the participant's source documents

- Must be comfortable with self-administration of nasal medication and be able to follow
the nasal administration instructions provided

- A woman of childbearing potential must have a negative highly sensitive serum (Beta
human chorionic gonadotropin [Beta hCG]) at screening and a negative urine pregnancy
test prior to the first dose of study intervention on Day 1 of the induction phase
prior to randomization

Exclusion Criteria:

- Depressive symptoms that have previously not responded to any of the following:

a Esketamine or ketamine in a major depressive episode per clinical judgment, or b All of
the classes of oral ADs in the study or an adequate AD augmentation/combination therapy in
the current major depressive episode, or c An adequate course of treatment with
electroconvulsive therapy in the current major depressive episode, defined as at least 7
treatments with unilateral/bilateral electroconvulsive therapy

- Received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in
the current episode of depression

- 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), intellectual
disability, autism spectrum disorder, borderline personality disorder, antisocial
personality disorder

- Has homicidal ideation or intent, per the investigator's clinical judgment; or has
suicidal ideation with some intent to act within 1 month prior to screening, per the
investigator's clinical judgment; or based on the Columbia Suicide Severity Rating
Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal
ideation with some intent to act, without specific plan) or Item 5 (active suicidal
ideation with specific plan and intent) for suicidal ideation on the C SSRS, or a
history of suicidal behavior within the past year prior to screening. Participants
reporting suicidal ideation with intent to act or suicidal behavior prior to the start
of the induction phase should also be excluded

- History of moderate or severe substance use disorder or severe alcohol use disorder
according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the
start of the screening or current clinical signs

- Has other inflammatory diseases that might confound the evaluations of benefit of
guselkumab therapy, including but not limited to Rheumatoid arthritis (RA), axial
spondyloarthritis (this does not include a primary diagnosis of psoriatic spondylitis
[PsA] with spondylitis), systemic lupus erythematosus, or Lyme disease