Comparing 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
PHASE4 · The George Institute · NCT06278779
This study is testing which form of ketamine, Spravato® or racemic ketamine, works better for people with treatment-resistant depression.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The George Institute (other) |
| Locations | 6 sites (Camperdown, New South Wales and 5 other locations) |
| Trial ID | NCT06278779 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with treatment-resistant depression who have not responded adequately to at least two different antidepressants.
Not a fit: Patients who cannot provide informed consent or have conditions that may interfere with study participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the most effective ketamine formulation for patients with treatment-resistant depression.
How similar studies have performed: Other studies have explored ketamine's effectiveness for depression, but this comparative approach between two formulations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 * 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 this trial is running
Camperdown, New South Wales and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Treatment Resistant Depression