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).

The study, conducted by the University of New South Wales and funded by NHMRC, spanned from August 15, 2016, to May 7, 2020, with participant enrolment taking place from August 15, 2016, to March 2, 2020.

The primary goal is to determine if ketamine is a viable and effective therapy for depression. Participants, diagnosed with Major Depressive Disorder (MDD) for at least 3 months and having inadequate responses to at least 2 antidepressant courses, undergo a 4-week randomised controlled phase with ketamine administered subcutaneously twice weekly.

The study evaluates various outcomes, including remission, changes in MADRS scores, anxiety levels, and suicidal ideation. The trial also investigates safety, tolerability, feasibility, and cost-effectiveness of repeated ketamine doses.

The study design is a randomised controlled trial in Phase III, recruiting in Australia (New South Wales). The results have not yet been published in a peer-reviewed journal.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Australia
Visit trial
Status Completed
Results Published No
Start date 15 August 2016
End date 07 May 2020
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 183
Sex All
Age 18- 99
Therapy No

Trial Details

The aim of this study is to determine if a course of ketamine is an effective therapy for depression. The study will also determine if repeated ketamine doses: 1) are safe, tolerable and feasible in outpatient settings; 2) provide sustained antidepressant benefits; 3) improve anxiety, suicidal ideation and health related quality of life; 4) are a cost effective treatment. 200 participants will be recruited across 6 sites in Australia (Black Dog Institute, Sydney; Royal Prince Alfred Hospital, Sydney; Monash Alfred Psychiatry Research Centre, Melbourne; South Eastern Private Hospital, Noble Park; Royal Adelaide Hospital, Adelaide; Gold Coast University Hospital, Gold Coast) and 1 in New Zealand (Dunedin, Otago). The study is a randomised controlled trial. Participants will be randomised to receive repeated doses of ketamine or a comparator treatment. For all participants, a follow-up assessment after finishing the randomised controlled phase will assess eligibility for an open label extension phase. All participants will be followed up after exiting the trial to assess treatment effects.

Trial Number ACTRN12616001096448

Sponsors & Collaborators

The University of New South Wales
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Data attribution

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