Evaluating the Positioning of Esketamine... — Clinical Trial Details

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.

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

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

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

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Study Arms & Interventions

Esketamine

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Inclusion Criteria

Exclusion Criteria

Study Details