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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06103760




Registration number
NCT06103760
Ethics application status
Date submitted
15/10/2023
Date registered
27/10/2023
Date last updated
17/05/2024

Titles & IDs
Public title
Positioning of Esketamine Treatment in the Real-world Management of Depression
Scientific title
Positioning of Esketamine Treatment in the Real-world Management of Depression
Secondary ID [1] 0 0
2023/PID01587
Universal Trial Number (UTN)
Trial acronym
PoET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Esketamine Nasal Spray [Spravato]

Other: Participants with Major Depressive Disorder - Intranasal esketamine to be self-administered by participants under direct supervision of a healthcare professional. First initial dose is 56mg and subsequent doses will be 56mg or 84mg. Esketamine will be administered twice weekly for weeks 1-4, once weekly for weeks 5-8, and once weekly/once fortnightly/once monthly as clinically indicated for weeks 9-25. After each treatment phase, participants will be re-assessed through a comprehensive battery of assessments and dose adjustments will be performed by the study psychiatrist base on tolerability, treatment response, and ongoing consent.


Treatment: Drugs: Esketamine Nasal Spray [Spravato]
This 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring.
Timepoint [1] 0 0
At the end of week 4
Primary outcome [2] 0 0
Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
Global functioning determined by Clinical Global Impression (CGI) score.
Timepoint [3] 0 0
Baseline, week 1, week 2, week 3, week 4 (primary time point), week 8 and week 12 after Esketamine was commenced.
Secondary outcome [1] 0 0
Change in mood symptom scores assessed using the visual analogue scale (self-reported)
Timepoint [1] 0 0
Baseline, after treatment day 1 and day 3 of each week until Esketamine is ceased.
Secondary outcome [2] 0 0
Depressive symptoms assessed using the Beck Depression Inventory (BDI) 21-Item.
Timepoint [2] 0 0
Baseline and at week 4 after Esketamine was commenced.
Secondary outcome [3] 0 0
Anxiety symptoms assessed using the State-Trait Anxiety Inventory (STAI)
Timepoint [3] 0 0
Baseline and at week 4 after Esketamine was commenced.

Eligibility
Key inclusion criteria
1. Adults aged 18-65 years old
2. Diagnosis of Major Depressive Disorder (MDD)
3. Currently depressed
4. Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)
5. Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment
6. Able to understand and provide informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concurrent diagnoses:

* 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
2. Pregnancy:

* 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
3. Current medications:

* Participants taking a total daily dose of benzodiazepines greater than the equivalent of 6mg/day of lorazepam
* Participants on complementary and alternative medicine therapies i.e., St John's wort, Chinese medicines, and various herbal and homeopathic treatments
4. Stimulants

* Participants taking stimulants such as methylphenidate, amphetamine, and dextroamphetamine for a diagnosis such as ADHD can still have Esketamine provided they do not continue taking stimulants concurrently for the duration of the study.
* Concurrent use is excluded due to the synergistic effect with Esketamine that can cause increased blood pressure.
5. Medical history:

* Participants with current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
* Participants with a history of uncontrolled hypertension
* Participants with uncontrolled diabetes mellitus
* Participants with aneurysmal vascular disease including thoracic and abdominal aorta, intracranial and peripheral arterial vessels, or arteriovenous malformation, intracerebral haemorrhage
* Participants with untreated glaucoma, current penetrating or perforating eye injury, brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure or increased intraocular pressure or planned eye surgery
* Participants who are currently receiving electroconvulsive therapy (ECT) or have received ECT in the past month.
6. Substance Misuse History:

* Participants who have ever had a substance misuse disorder involving any of the following over their lifetime: ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3,4-methylenedioxy-methamphetamine (MDMA), or other hallucinogen use history
* Participants with hypersensitivity to Esketamine, Ketamine, or any of the excipients

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/01/2026
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen-Cilag Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT06103760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gin Malhi
Address 0 0
Royal North Shore Hospital, University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Erica Bell
Address 0 0
Country 0 0
Phone 0 0
02 9462 9905
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06103760