Clinical TrialTreatment-Resistant Depression (TRD)KetamineEsketamineRecruiting

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

This interventional trial, led by The George Institute, aims to compare the effectiveness of two formulations of ketamine (esketamine (Spravato®) and racemic ketamine), in treating treatment-resistant depression (TRD).

Target Enrollment
162 participants
Study Type
Phase IV interventional
Design
Randomized, single Blind

Detailed Description

Randomised, prospective, rater-blinded (outcome assessors) parallel-group comparative effectiveness trial comparing racemic IV ketamine and intranasal esketamine (Spravato®) in people with treatment-resistant depression.

Primary outcomes include comparative effectiveness on depressive symptoms after initial treatment; secondary outcomes include acceptability, safety, quality of life, function and health-economic endpoints with follow-up from 4 weeks to 6 months. Treatments are delivered in participating ketamine clinics following clinic protocols with randomisation to one of the two modalities.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

Racemic ketamine

experimental

IV racemic ketamine with clinic-guided dose optimisation and titration.

Interventions

  • Ketamine0.5 - 1.5 mg/kg
    via IV• twice weekly then per clinic• 8 doses total

    Typical starting 0.5 mg/kg; titration to max 1.5 mg/kg as needed.

Esketamine (Spravato)

active comparator

Intranasal esketamine dosing per Spravato® product information with clinic-guided adjustments.

Interventions

  • Esketamine56 - 84 mg
    via Other• twice weekly then weekly then maintenance

    Intranasal Spravato®: starting dose 28 or 56 mg (≥65 start 28 mg); options 28/56/84 mg; Weeks1–4 twice weekly, Weeks5–8 weekly, then maintenance.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
Black Dog Institute — Randwick, New South Wales, Australia
Ramsay Clinic Northside — St Leonards, New South Wales, Australia
Ramsay Clinic Lakeside — Warners Bay, New South Wales, Australia
Gold Coast University Hospital — Southport, Queensland, Australia
Ramsay Clinic Albert Road — Melbourne, Victoria, Australia

Your Library