Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06278779

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

Led by The George Institute · Updated on 2025-06-03

162

Participants Needed

6

Research Sites

147 weeks

Total Duration

On this page

Sponsors

T

The George Institute

Lead Sponsor

T

The University of New South Wales

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult with treatment-resistant depression who has a current depressive episode
  • Assessed by clinic psychiatrist as appropriate for racemic ketamine or Spravato4 treatment
  • Aged 18 years or older
  • Provided written informed consent for research study
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Any physical or mental condition that could interfere with study participation or assessments
  • Requires an interpreter for clinic consent process, making research assessments infeasible

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

2

Black Dog Institute

Randwick, New South Wales, Australia, 2031

Actively Recruiting

3

Ramsay Clinic Northside

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

4

Ramsay Clinic Lakeside

Warners Bay, New South Wales, Australia, 2282

Actively Recruiting

5

Gold Coast University Hospital

Southport, Queensland, Australia, 4215

Actively Recruiting

6

Ramsay Clinic Albert Road

Melbourne, Victoria, Australia, 3004

Actively Recruiting

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Research Team

A

Abigail Hansen

CONTACT

F

Fay Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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