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
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 April 2024
End date 30 April 2027
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 162
Sex All
Age 18- 99
Therapy No

Trial Details

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.

NCT Number NCT06278779

Data attribution

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