A randomised controlled trial of oral S-ketamine as add-on medication for patients with treatment-resistant major depressive disorder

This double-blind, placebo-controlled trial (n=128) investigates the antidepressant efficacy of oral esketamine as an add-on medication for patients with treatment-resistant major depressive disorder (TRD).

Conducted by the University Medical Centre Groningen in the Netherlands, the trial aims to assess changes in symptom severity using the HDRS17 scale and explore various secondary endpoints, including effects on sleep, memory, anxiety, and brain activity.

The study involves adults aged 18-80 with TRD and employs a randomised controlled design with a placebo group. The treatment duration is six weeks, with follow-up evaluations at weeks 7, 8, and 10. The trial, sponsored by ZonMw, incorporates multiple sites and has been ongoing since August 30, 2016.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Netherlands
Visit trial
Status Active, not recruiting
Results Published No
Start date 29 August 2016
End date 30 December 2024
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 128
Sex All
Age 18- 80
Therapy Yes

Trial Details

Ongoing in the Netherlands, this double-blind, placebo-controlled trial (n=128) explores the antidepressant effects of oral S-ketamine as an add-on for treatment-resistant major depressive disorder. Sponsored by ZonMw, conducted by the University Medical Centre Groningen, and initiated on August 30, 2016, the study assesses changes in symptom severity using HDRS17 over six weeks. Multiple sites are involved, with secondary endpoints including effects on sleep, memory, anxiety, and brain activity, followed up at weeks 7, 8, and 10.

NCT Number 2015-003957-16

Sponsors & Collaborators

University of Groningen
The University of Groningen, established in 1614, is a prestigious institution that ranks among the world's top universities. It has taken a pioneering role in the interdisciplinary research of psychedelics, harnessing its rich academic heritage and a forward-looking approach to exploring the potential of psychedelic substances in treating various mental health conditions.

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