Clinical Trial

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

Study acronym: TREK
Recruiting Phase 4
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Summary
The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD. * How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness. Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-02-19; most recent amendment 2026-05-27.
Status change: Not Yet Recruiting → Recruiting 2024-06-03
Trial Details
NCT Number NCT06278779
Lead Sponsor The George Institute
Collaborators: The University of New South Wales
Conditions Treatment Resistant Depression
Enrollment 162 participants
Start Date 2024-06-03
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-29