RESET-TRD A randomised trial on oral esketamine compared to electroconvulsive therapy in patients with treatment-resistant depression. Research
A randomised trial on oral esketamine compared to electroconvulsive therapy in patients with treatment-resistant depression.
Depression is one of the most impactful medical conditions worldwide, a leading cause of disability, and a major contributor to the overall global burden of disease. A novel intervention that has shown rapid and robust antidepressant effects is esketamine treatment.

For patients with depression response to treatment is rather unpredictable, slow in onset, and incomplete in success rate. Stepwise protocolled treatment fails to achieve a clinically meaningful response in approximately 30% of patients with depression. Professional guidelines advise electroconvulsive therapy (ECT) as the final treatment step for patients with TRD. ECT, however, entails considerable disadvantages: the procedure requires repeated anaesthesia and clinical admission, there is a risk of persistent and significant cognitive side effects, and 40% of patients relapse within six months. Hence, there is a pressing need for efficacious alternatives for patients with TRD. Esketamine appears to have robust immediate results on the reduction of depressive symptoms. Oral formulation of esketamine can be used for longer periods of time and is safe to use at home but is not yet registered for use in depression. Given its promising effects and presumed advantages, an important question is whether oral esketamine may serve as an effective and acceptable alternative to ECT.  

Relevance

How our research benefits to society

In this multicentre randomized trial we will investigate whether oral esketamine is non-inferior to ECT after eight weeks of individually optimized treatment and compare the long-term effectiveness. We will also investigate whether oral esketamine is more patient friendly than ECT with respect to treatment burden, side effects, and tolerability. And if treatment with oral esketamine is more cost-effective compared to ECT. The answers to these questions will be used by Zorginstituut Nederland to decide whether oral esketamine in the future can be reimbursed for severe depression. Parnassia/PsyQ Den Haag, LUMC Leiden, Pro Persona Nijmegen and GGZinGeest/Amsterdam UMC in Amsterdam will all be participating in this UCP/UMCG based study. 

Timeline

  1. Inclusion has started at the UCP/UMCG

    Posted

    Inclusion has started at the UCP/UMCG! Other participating centers will follow soon.  We will randomize participants to receive standard ECT treatment or oral esketamine treatment.  Participants receiving the oral esketamine treatment will be guided at their sessions by trained staff to help them with the psychedelic experience and get the most out of there session. This training has been designed specially for our study.  

Contact

University Medical Center Groningen (UMCG)
University Center of Psychiatry (UCP) - RESET-TRD
PO Box 30.001
9700 RB Groningen
The Netherlands

Visiting address
University Medical Center Groningen (UMCG)
University Center of Psychiatry (UCP) - RESET-TRD
Hanzeplein 1, Triadegebouw
9713 GZ Groningen