Positioning of Esketamine Treatment in the Real-world Management of Depression
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRoyal North Shore Hospital
About this trial
The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are:
* to investigate whether Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice
Participants will:
* attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-65 years old
Diagnosis of Major Depressive Disorder (MDD)
Currently depressed
Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)
Disqualifiers
Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia
Participants who are unable to understand the study and therefore unable to provide informed consent
Participants who are pregnant and/or breastfeeding
Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods
Trial design
Design model
Single group
Treatments tested in this trial
Esketamine Nasal Spray [Spravato]
DrugThis is an uncontrolled, single arm, naturalistic study. There will be three treatment phases: Phase 1 - Acute treatment phase (weeks 1-4); Phase 2 - Maintenance treatment phase (weeks 5-8); Phase 3 - Continuation treatment phase (Weeks 9-25). Phase 1 is the critical component of our study as it determines our primary outcomes.
Treatment groups
162 Participants
are divided into 1 treatment groupGroup A: Participants with Major Depressive DisorderOther 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring.
Hamilton Depression Rating Scale (HAM-D) 17-Item scoring
Time frame
At the end of week 42
Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.
Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.
Time frame
Baseline, at the end of weeks 1,2,3, and 4 (primary time point); and further after week 8 and week 12 after Esketamine was commenced.3
Global functioning determined by Clinical Global Impression (CGI) score.
Clinical Global Impression (CGI)
Time frame
Baseline, week 1, week 2, week 3, week 4 (primary time point), week 8 and week 12 after Esketamine was commenced.Secondary outcomes
1
Change in mood symptom scores assessed using the visual analogue scale (self-reported)
Visual analogue scale (self-reported)
Time frame
Baseline, after treatment day 1 and day 3 of each week until Esketamine is ceased.2
Depressive symptoms assessed using the Beck Depression Inventory (BDI) 21-Item.
Beck Depression Inventory (BDI) 21-Item.
Time frame
Baseline and at week 4 after Esketamine was commenced.3
Anxiety symptoms assessed using the State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI)
Time frame
Baseline and at week 4 after Esketamine was commenced.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal North Shore Hospital
Lead sponsor
Janssen-Cilag Pty Ltd
Collaborator
Source ClinicalTrials.gov