Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression (TREK)

This interventional trial, led by The George Institute, aims to compare the effectiveness of two formulations of ketamine (esketamine (Spravato®) and racemic ketamine), in treating treatment-resistant depression (TRD).

The trial, known as TREK, is a randomised, prospective, rater-blinded study involving parallel groups. Participants, recruited from clinics providing ketamine treatment services for TRD, will be randomised to receive either Spravato® or racemic ketamine treatment. The study will assess treatment effects on mood, acceptability, safety, quality of life, function, and cost-effectiveness using various questionnaires.

Primary outcome measures include changes in scores on the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Secondary outcome measures encompass a range of psychological and functional assessments.

Recruitment for the study is estimated to enroll 162 participants and is anticipated to start in April 2024, with completion expected by April 2027. The study will involve several locations across Australia, including New South Wales, Queensland, and Victoria.

Topic Depression Treatment-Resistant Depression Safety
Compound Ketamine
Country Australia
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