This interventional trial (n=60) will assess the efficacy and safety of Ketamine-Assisted Psychotherapy (KAP) involving Behavioural Activation Therapy (BAT) in adults with Treatment-Resistant Major Depressive Disorder (TRD).
Participants will be randomised to receive oral ketamine plus BAT or oral ketamine plus Treatment As Usual (TAU). Ketamine will be administered orally at varying doses, with BAT consisting of 12 sessions over 8 weeks, designed to complement the ketamine treatment.
The study aims to test the feasibility of this combined approach and hypothesises that adding BAT to oral ketamine treatment will prolong the response and delay relapse for three months after treatment ends. The trial will assess feasibility, treatment acceptability, and safety, with outcomes including study attendance, depression severity, cognitive function, activity levels, and adverse events.
The trial is not yet recruiting and is expected to run from February 10, 2023, to July 20, 2026, in New Zealand. The trial is funded by the Health Research Council and conducted by the University of Otago, with Dr. Ben Beaglehole serving as the principal investigator.
Trial Details
Our study will compare oral ketamine treatment with oral ketamine treatment and Behavioural Activation Therapy (BAT) for patients with treatment resistant depression. We will test the feasibility of providing oral ketamine and BAT over 8 weeks in a study. We hypothesise that adding BAT to oral ketamine treatment will prolong the response and delay relapse for three months after treatment ends. We also hypothesise that BAT and oral ketamine will be well tolerated by participants.NCT Number ACTRN12623000817640p
Sponsors & Collaborators
University of OtagoThe University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.