Comparing two forms of ketamine for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of two formulations of ketamine, Spravato® and racemic ketamine, in treating individuals with treatment-resistant depression (TRD). Participants will be randomly assigned to receive either treatment and will complete questionnaires to evaluate mood, treatment acceptability, side effects, quality of life, and cost-effectiveness. The study will assess these outcomes over a treatment period of 4 weeks to 6 months, providing insights into the relative benefits of each formulation. The research is conducted in collaboration with clinics that offer these treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)
* Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD
* MADRS score of ≥20 at study baseline, assessed by certified study rater
* Aged ≥18 years
* Written informed consent for research study obtained

Exclusion Criteria:

* Not able to give informed consent
* Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments
* Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study
* Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales

Where it's running

• Royal Prince Alfred Hospital
  Camperdown, New South Wales, Australia Recruiting
• Black Dog Institute
  Randwick, New South Wales, Australia Recruiting
• Ramsay Clinic Northside
  St Leonards, New South Wales, Australia Recruiting
• Ramsay Clinic Lakeside
  Warners Bay, New South Wales, Australia Recruiting
• Gold Coast University Hospital
  Southport, Queensland, Australia Recruiting
• Ramsay Clinic Albert Road
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Colleen Loo — The University of New South Wales
• Study coordinator: Abigail Hansen
• Email: Trek@georgeinstitute.org.au
• Phone: 80524300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.