NCT06103760RecruitingPhase 4
Positioning of Esketamine Treatment in the Real-world Management of Depression
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 15 Oct 2023
- Start date
- 31 Oct 2023
- Primary completion date
- 15 Dec 2027
- Lead sponsor
- Royal North Shore Hospital
- Diseases
- Depression
- NCT number
- NCT06103760
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 162
- From 31 Oct 2023 to the primary completion date, 15 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- 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.
- 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.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
- Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment
- Able to understand and provide informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.