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RecruitingPhase 4NCT06278779

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

Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial

Sponsor

The George Institute

Enrollment

162 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Treatment Resistant Depression

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two forms of ketamine — intravenous (IV) racemic ketamine and intranasal esketamine (Spravato) — for treating depression that has not responded to at least two antidepressants (called treatment-resistant depression). The goal is to see which form works better in real-world clinical practice. **You may be eligible if...** - You are 18 years or older - You have treatment-resistant depression (failed at least 2 antidepressants at adequate doses) - You are currently experiencing a depressive episode - Your psychiatrist has assessed you as appropriate for ketamine treatment - You are able to provide written informed consent **You may NOT be eligible if...** - You are unable to give informed consent - You have a physical or mental condition that would interfere with study participation - You need an interpreter for the consent process (due to feasibility constraints on study assessments) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsketamine 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

DRUGRacemic 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

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NCT06278779

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