Clinical TrialMajor Depressive Disorder (MDD)EsketamineNot yet recruiting

Evaluating the Positioning of Esketamine Treatment (PoET) for symptom management in adults with major depressive disorder

This uncontrolled, single-arm, naturalistic study (n=162) aims to evaluate the positioning of Esketamine Treatment (PoET) for symptom management in adults with major depressive disorder (MDD).

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

Detailed Description

Single-arm, uncontrolled phase IV naturalistic study (n=162) evaluating intranasal esketamine (initial 56 mg; subsequent 56 or 84 mg) administered under supervision in the CADE clinic across three treatment phases: acute (weeks 1–4), maintenance (weeks 5–8) and continuation (weeks 9–25). Primary outcome is proportion of treatment responders (≥50% reduction in HAM-D-17).

Dosing schedule: twice weekly in weeks 1–4, once weekly in weeks 5–8, then weekly/fortnightly/monthly as clinically indicated during weeks 9–25. Assessments at baseline and after each administration; dose adjustments performed by the study psychiatrist based on tolerability and response.

Study Arms & Interventions

Esketamine

experimental

Open-label, single-arm intranasal esketamine treatment (PoET) across acute, maintenance and continuation phases.

Interventions

  • Esketamine56 - 84 mg
    via Other• twice weekly (weeks 1–4); once weekly (weeks 5–8); maintenance individually determined (weeks 9–25)

    Intranasal spray; supervised self-administration in clinic; dose adjustments (56 or 84 mg) per psychiatrist discretion

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 1. Be an adult aged 18–65 years old
  • 2. Have a primary diagnosis of Major Depressive Disorder (MDD)
  • 3. A co-morbid diagnosis of an anxiety disorder or ADHD can be included
  • 4. Be currently depressed and on medication for current episode
  • 5. Have experienced an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)
  • 6. Be maintained on their current antidepressant medication or psychological therapy at the time of enrolment
  • 7. Able to understand and able to provide informed consent

Exclusion Criteria

  • 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 unwilling 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 6 mg/day of lorazepam; participants on complementary and alternative medicine therapies (e.g., St John’s wort, Chinese medicines, herbal/homeopathic treatments)
  • 4. Stimulants: participants taking stimulants (methylphenidate, amphetamine, dextroamphetamine) for ADHD may receive esketamine only if they do not continue stimulants concurrently for study duration; concurrent use excluded due to synergistic BP effects
  • 5. Medical history: participants with current or past history of seizures (uncomplicated childhood febrile seizures without sequelae are not exclusionary); history of uncontrolled hypertension; uncontrolled diabetes mellitus; aneurysmal vascular disease or arteriovenous malformation; untreated glaucoma or conditions associated with increased intracranial/intraocular pressure; recent or planned eye surgery; participants currently receiving ECT or received ECT in past month
  • 6. Substance misuse history: lifetime substance misuse disorder involving ketamine, PCP, LSD, MDMA or other hallucinogens
  • 7. Hypersensitivity to esketamine, ketamine, or any excipients

Study Details

Locations

Unknown facility — Australia

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