Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

Effectiveness of ketamine therapy among patients with treatment-resistant depression: a double-blind, randomised, controlled trial

This double-blind, randomised, controlled trial (n=183), known as the Ketamine for Adult Depression Study (KADS), explored the effectiveness of ketamine therapy in treating patients with treatment-resistant depression (TRD).

Target Enrollment
183 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind RCT phase: subcutaneous ketamine (100 mg/mL) given twice weekly for 4 weeks; participants screened 1 month after RCT for eligibility to enter a 4-week open-label extension after a 1-month break.

Dosing is weight-based by volume (0.22–0.53 mL starting volumes depending on body weight) with the possibility of dose increases up to 0.91 mL; adherence ensured by staff-administered injections. Primary outcome: remission at end of RCT phase (MADRS <10); MADRS change also assessed.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Subcutaneous ketamine administered twice weekly for 4 weeks (RCT phase) with optional 4-week open-label extension after 1-month break.

Interventions

  • Ketamine0.22 - 0.91 ml
    via Other• twice weekly• 8 doses total

    Concentration 100 mg/mL; starting volume based on body weight (see table); subcutaneous injection. Starting volumes: 41-45 kg 0.22 mL; 46-50 kg 0.24 mL; 51-55 kg 0.27 mL; 56-60 kg 0.29 mL; 61-70 kg 0.33 mL; 71-80 kg 0.38 mL; 81-90 kg 0.43 mL; 91-100 kg 0.48 mL; >100 kg 0.53 mL. Dose may be increased depending on tolerability; maximum 0.91 mL.

Active control

active comparator

Active control drug administered during RCT (unspecified in source text).

Interventions

  • Compound

    Specified only as an active control in source text; agent and dosing not provided.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Criteria assessed by the research team include:
  • Major Depressive Disorder (MDD) for at least 3 months.
  • An inadequate response to at least 2 adequate antidepressant courses; stable dose of antidepressant medications at least 4 weeks prior to trial entry.
  • Montgomery Åsberg Depression Rating Scale (MADRS) score of at least 20.

Exclusion Criteria

  • Criteria assessed by the research team to determine suitability include:
  • Psychotic disorder.
  • Bipolar disorder.
  • Medical and neurologic conditions.
  • Psychiatric disorders other than MDD.
  • Planned major changes to psychotropic medication.
  • Planned or probable use of ECT.
  • Risk of suicide.
  • Substance use, abuse, dependence.
  • Recent or planned ketamine treatment.
  • Medical conditions in which use of ketamine or sedating medications may pose a significant health risk.
  • Women of childbearing potential not taking reliable contraception.
  • Inability to complete the trial.

Study Details

Locations

Unknown facility — Australia

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