A randomised, double blind, active placebo-controlled crossover trial to evaluate the short term efficacy of an N-Methyl-D-Aspartate antagonist for patients with treatment resistant depression

This randomised, double-blind, active placebo-controlled crossover trial (n=30) investigates the short-term efficacy of ketamine for patients with treatment-resistant depression (TRD).

Registered on ANZCTR, the trial, conducted in New Zealand by the University of Auckland, commenced enrolment on August 1, 2016, and was completed on August 16, 2018.

Led by Dr Suresh Muthukumaraswamy, the study explores the use of Ketamine IV (bolus dose 0.25mg/kg, followed by infusion at 0.25 mg/kg/hr for 45 minutes) with a 3-week washout period. Participants, aged 18 to 60, diagnosed with major depressive disorder for at least three months and showing an inadequate response to at least two antidepressant courses, will undergo follow-ups at 1, 7, 14, and 21 days.

Primary outcomes include the Montgomery-Asberg Depressive Rating Scale (MADRS) assessed 4 hours post-administration. Secondary outcomes involve BDNF plasma concentration and functional connectivity measured with EEG.

The trial aims to understand the rapid antidepressant effects of ketamine using brain imaging and blood biomarkers. Results have been published in the “Biol Psychiatry Cogn Neurosci Neuroimaging” journal on January 2020.

Topic Treatment-Resistant Depression Depression
Compound Ketamine Placebo
Country New Zealand
Visit trial
Status Completed
Results Published Yes
Start date 27 October 2016
End date 05 October 2018
Phase Phase II Phase III
Design Blinded
Type Interventional
Generation First
Participants 30
Sex All
Age 18- 60
Therapy No

Trial Details

Depression is the most prevalent mental health disorder in New Zealand. Although many treatments are available for approximately one third of patients these treatments will be ineffective and they will be classified as "treatment-resistant". New research indicates that the approved medicine ketamine given at low doses can be used successfully as antidepressant in approximately two thirds of patients with treatment resistant depression. Moreover ketamine’s rapid antidepressant actions, within several hours, make it remarkable compared to usual therapies. In addition to offering hope to patients, for scientists studying depression ketamine allows new opportunities to study the disease. In this study we will give patients with treatment-resistant depression ketamine to rapidly move them from a state of depression to nondepression. We will use brain imaging technologies and blood biomarkers to attempt to understand what processes occur in these patients that underlie the transition to elevated mood.

NCT Number ACTRN12615000573550

Data attribution

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