Positioning of Esketamine Treatment (PoET) in the real-world management of depressio
- Conditions
- Major Depressive DisorderMental Health - Depression
- Registration Number
- ACTRN12623001068651
- Lead Sponsor
- orthern Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 162
1. Be an adult aged 18-65 years old
2. Have a primary diagnosis of Major Depressive Disorder (MDD)
***Please note: a co-morbid diagnosis of an anxiety disorder or ADHD can be included***
3. Be currently depressed and on medication for current episode
4. Have experienced 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 enrolment
6. Able to understand and able to provide informed consent
1.Concurrent diagnoses
-Participants with DSM-5 disorders 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-methamhetamine (MDMA), or other hallucinogen use history
-Participants with hypersensitivity to Esketamine, Ketamine, or any of the excipients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring.[ At the conclusion of the study];Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.[ Baseline, after first treatment, 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.];Global functioning determined by Clinical Global Impression (CGI) score.[ Baseline, week 1, week 2, week 3, week 4 (primary time point), week 8 and week 12 after Esketamine was commenced.]
- Secondary Outcome Measures
Name Time Method Change in mood symptom scores assessed using the visual analogue scale (self-reported).[ Baseline and following each administration of Esketamine until this is ceased.];Depressive symptoms assessed using the Beck Depression Inventory (BDI) 21-Item.[ Baseline and at week 4 after Esketamine was commenced.];Anxiety symptoms assessed using the State-Trait Anxiety Inventory (STAI)[ Baseline and at week 4 after Esketamine was commenced. ]