Using Esketamine to Treat Depression in Real-world Settings

Positioning of Esketamine Treatment in the Real-world Management of Depression

This study is testing if adding a nasal spray called Esketamine to regular antidepressant treatment can help people with Major Depressive Disorder feel better in real-life settings.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Royal North Shore Hospital (Academic / other)
• Locations: 1 site (St Leonards, New South Wales)
• Trial ID: NCT06103760 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm intervention study aims to evaluate the effectiveness of Esketamine when added to ongoing antidepressant treatment for patients with Major Depressive Disorder. Participants will self-administer intranasal Esketamine under supervision and will be monitored for two hours post-administration. The study also seeks to identify patient characteristics that may predict a therapeutic response to Esketamine in real-world clinical practice. Participants will complete questionnaires and will be reimbursed for travel expenses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of Major Depressive Disorder who have not adequately responded to two or more courses of antidepressants.

Not a fit: Patients with concurrent psychiatric disorders, such as bipolar disorder or schizophrenia, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how Esketamine can enhance treatment outcomes for patients with depression who have not fully responded to traditional antidepressants.

How similar studies have performed: Other studies have shown promising results with Esketamine for treatment-resistant depression, indicating that this approach is gaining traction in clinical settings.

Eligibility criteria

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

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

Where this trial is running

St Leonards, New South Wales

• Royal North Shore Hospital — St Leonards, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Gin Malhi — Royal North Shore Hospital, University of Sydney
• Study coordinator: Erica Bell

Conditions Major Depressive Disorder; Depression