This open-label feasibility study (n=30) of ketamine-assisted therapy aims to assess the potential effectiveness and feasibility of using ketamine in combination with psychotherapy to treat treatment-resistant depression (TRD) in adults.
The trial involves administering ketamine intramuscularly in three consecutive weekly sessions, each followed by integration psychotherapy sessions within 2 days.
The study, conducted by the University of Auckland, New Zealand, under the leadership of Dr. Nicholas Hoeh, will include 30 participants recruited from the Auckland region. The primary outcome measure is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) score, evaluated at various time points post-treatment, including 4 hours and 1 day after each ketamine session, and up to 6 months following the final session. Secondary outcomes include changes in anxiety symptoms, altered states of consciousness, personality traits, mental wellness, and therapeutic alliance.
The trial, funded by The Oakley Mental Health Foundation, commenced enrolment on 8th August 2022, with a target sample size of 30 participants. The study received ethics approval from the Northern A Health and Disability Ethics Committee. Data sharing for individual participant data is not available due to the small sample size and the vulnerable population involved in the study. For further information, individuals can contact Dr. Nicholas Hoeh at [email protected].
Trial Details
In this study, we will recruit from an adult population with treatment-resistant depression throughout the Auckland region. The primary goal of our research is to find out if ketamine given in a therapeutic context combined with psychological support and integration can be tolerated and reduce symptoms of depression.The study is also designed to explore the practical aspects of designing a larger study in the future. After appropriate screening and informed consent, each participant will receive three intramuscular ketamine injections in combination with a brief psychotherapeutic intervention in consecutive weeks. The sample size will be thirty participants. The primary outcome measure will be the clinical benefit as based on percentage change in the Montgomery-Asberg Depression Rating Scale (MADRS) at 4hr and 1 day post each ketamine treatment, 7 days, 28 days, 3 months, and 6 months days post final treatment. This is a feasibility study to explore the testing study procedures, validity of tools, and recruitment rate in order to design a larger study involving use of ketamine in combination with psychotherapy for the treatment-resistant population.NCT Number ACTRN12621000562875