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).
Details
Randomised, prospective, rater-blinded (outcome assessors) parallel-group comparative effectiveness trial comparing racemic IV ketamine and intranasal esketamine (Spravato®) in people with treatment-resistant depression.
Primary outcomes include comparative effectiveness on depressive symptoms after initial treatment; secondary outcomes include acceptability, safety, quality of life, function and health-economic endpoints with follow-up from 4 weeks to 6 months. Treatments are delivered in participating ketamine clinics following clinic protocols with randomisation to one of the two modalities.