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

Last updated: April 7, 2025
Sponsor: The George Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Depression

Treatment

Racemic ketamine

Esketamine group

Clinical Study ID

NCT06278779
X23-0311
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult with treatment-resistant depression (TRD: not responded adequately to at leasttwo different antidepressants of adequate dose and duration) who has a currentdepressive episode (DSM 5)

  • Assessed and attested by clinic psychiatrist as appropriate to receive eitherracemic ketamine or Spravato® ketamine treatment for TRD

  • Aged ≥18 years

  • Written informed consent for research study obtained

Exclusion

Exclusion Criteria:

  • Not able to give informed consent

  • Any physical or mental condition which, in the opinion of the investigator, couldinterfere with study participation including outcome assessments

  • Patients who require an interpreter/translator for the clinic consent process, dueto the infeasibility of obtaining an interpreter for research assessments, includingself-rated scales

Study Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Racemic ketamine
Phase: 4
Study Start date:
June 03, 2024
Estimated Completion Date:
April 30, 2027

Study Description

The TREK study is a randomized, prospective, rater blinded (primary outcome raters), parallel group, comparative effectiveness trial of racemic ketamine and Spravato®, comparing their effectiveness, acceptability, safety, effects on quality of life (QOL), function and cost effectiveness after 4 weeks - 6 months of treatment in people with TRD.

Participants will be recruited from clinics/hospitals that are providing racemic ketamine and Spravato® treatment services for TRD. Participants will be referred, treated and followed up as per the clinic's normal clinical practice. Participants who consent to participate in this research study will undergo other processes in addition to the standard treatment procedures provided by their clinic:

  • Randomisation to receive racemic ketamine or Spravato®.

  • Completion of questionnaires to measure treatment effects on mood, acceptability, safety, quality of life and function and cost effectiveness.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Black Dog Institute

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Ramsay Clinic Northside

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Ramsay Clinic Lakeside

    Warners Bay, New South Wales 2282
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Ramsay Clinic Albert Road

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria 3052
    Australia

    Site Not Available

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