Ketamine versus Ketamine plus Behavioural Activation Therapy for Adults with Treatment Resistant Depression

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.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country New Zealand
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Trial Details



Trial Number

Sponsors & Collaborators

University of Otago
The University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.

Data attribution

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