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RecruitingPhase 4

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

NCT06278779 · TREK · The George Institute

Recruiting
Status
Accepting participants
Phase 4
Phase
162
Target enrolment
7
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured over From week 0 to week 4.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

7 study sites

FacilityCityRegionCountry
Royal Prince Alfred HospitalCamperdownNew South WalesAustralia
Black Dog InstituteRandwickNew South WalesAustralia
Ramsay Clinic NorthsideSt LeonardsNew South WalesAustralia
Ramsay Clinic LakesideWarners BayNew South WalesAustralia
Gold Coast University HospitalSouthportQueenslandAustralia
Ramsay Clinic Albert RoadMelbourneVictoriaAustralia
Royal Melbourne HospitalParkvilleVictoriaAustralia

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06278779 on ClinicalTrials.gov →

Last updated in the registry 2026-05-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance