Clinical TrialMajor Depressive Disorder (MDD)KetamineRecruiting

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

This naturalistic, open-label, single-arm intervention trial (n=162) conducted by Royal North Shore Hospital assesses add-on intranasal esketamine (Spravato) for adults with major depressive disorder.

Target Enrollment
162 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Open-label, single-group study of intranasal esketamine administered under supervision as an add-on to ongoing antidepressant treatment across acute (weeks 1–4), maintenance (weeks 5–8) and continuation (weeks 9–25) phases.

Primary aims are to evaluate effectiveness of esketamine in real-world practice and to identify patient characteristics associated with therapeutic response; participants are observed for two hours after dosing with blood pressure monitoring and complete questionnaires and reassessments for dose adjustment.

Study Arms & Interventions

Esketamine (Spravato)

experimental

Supervised intranasal esketamine administered as add-on to ongoing antidepressant treatment across acute, maintenance and continuation phases with dose adjustments by study psychiatrist.

Interventions

  • Ketamine56 - 84 mg
    via Other• Twice weekly (weeks 1–4), once weekly (weeks 5–8), then individualized once weekly/fortnightly/monthly (weeks 9–25)

    Intranasal Spravato; initial 56 mg, subsequent 56 mg or 84 mg as clinically indicated; observed 2 hours post-dose with BP monitoring.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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 enrolment
  • 6. Able to understand and provide informed consent

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Concurrent diagnoses: participants with other DSM-5 diagnoses (e.g., current substance misuse disorder, bipolar disorder, schizophrenia) or unable to understand the study and provide informed consent
  • 2. Pregnancy/breastfeeding or unwillingness to avoid pregnancy during the study
  • 3. Current medications: total daily benzodiazepines > equivalent of 6 mg lorazepam; use of complementary/alternative medicines (e.g., St John's wort)
  • 4. Stimulants: participants taking stimulants for ADHD may be excluded if they continue concurrent stimulant use during the study due to blood pressure risk
  • 5. Medical history: current or past seizures (except uncomplicated childhood febrile seizures), uncontrolled hypertension, uncontrolled diabetes, aneurysmal vascular disease, untreated glaucoma or conditions increasing intracranial/intraocular pressure, recent ECT (within past month)
  • 6. Substance misuse history: lifetime misuse disorder involving ketamine, PCP, LSD, MDMA or other hallucinogens; hypersensitivity to esketamine, ketamine, or excipients

Study Details

Locations

Royal North Shore Hospital — St Leonards, New South Wales, Australia

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