NCT06278779RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 20 Jan 2024
- Start date
- 3 Jun 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- The George Institute
- Diseases
- Depression
- NCT number
- NCT06278779
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 162
- From 3 Jun 2024 to the primary completion date, Apr 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study
Other illness
- Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments
Other
- Not able to give informed consent
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Ramsay Clinic Albert Road Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Black Dog Institute Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Ramsay Clinic Northside Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Ramsay Clinic Lakeside Coordinator of this site? Confirm its status | Warners Bay | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.