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Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
Sponsor: The George Institute
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.
Official title: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2024-06-03
Completion Date
2027-04
Last Updated
2025-06-03
Healthy Volunteers
No
Conditions
Interventions
Esketamine group
The recommended dosing for Spravato is: Weeks 1-4: Starting Day 1 dose: \< 65 years: 56 mg ≥ 65 years: 28 mg Subsequent doses: 28 mg (≥ 65 years), 56 mg or 84 mg twice weekly Weeks 5-8: 28 mg (≥ 65 years), 56 mg or 84 mg once weekly From Week 9: 28 mg (≥ 65 years), 56 mg or 84 mg every 2 weeks or once weekly
Racemic ketamine
Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted as needed using an ascending dose titration schedule: 1. 0.5 mg/kg 2. 0.6 mg/kg 3. 0.75 mg/kg 4. 0.9 mg/kg 5. Further increments by 0.1-0.2 mg/kg, up to max 1.5 mg/kg
Locations (6)
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Black Dog Institute
Randwick, New South Wales, Australia
Ramsay Clinic Northside
St Leonards, New South Wales, Australia
Ramsay Clinic Lakeside
Warners Bay, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia