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

Study acronym: TREK
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 6 to 7 Eligibility criteria expanded, about 30 words · Secondary endpoints: 25 to 28v11 Show 2 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 25 to 28

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv10
  3. Site details revised at 1 of 6 sitesv9
  4. Re-verified, no change to tracked fieldsv8
  5. Secondary endpoints: 23 to 25 Site details revised at 2 of 6 sitesv7 Show 1 more changeShow less
    • Site details revised at 2 of 6 sites

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 2 of 6 sitesv6
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2024 to Jun 3, 2024 · Site details revised at 6 of 6 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of May 2024 to Jun 3, 2024
    • Site details revised at 6 of 6 sites
  3. Start date: Apr 2024 to May 2024 Secondary endpoints: 21 to 23v4 Show 1 more changeShow less
    • Secondary endpoints: 21 to 23

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: Mar 2027 to Apr 2027 Start date: Mar 2024 to Apr 2024 · Site contacts updated at 2 of 6 sitesv3 Show 2 more changesShow less
    • Start date: Mar 2024 to Apr 2024
    • Site contacts updated at 2 of 6 sites
  5. Study sites: 7 to 6v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The George Institute
19 trials monitored
See 1 trial at risk
Depression
2,998 trials monitored
See 166 trials at risk
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.
Trial Details
NCT Number NCT06278779
Lead Sponsor The George Institute
Collaborators: The University of New South Wales
Conditions Treatment Resistant Depression
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov