Oral ketamine as an additional treatment in patients with treatment-resistant depression

This double-blind, randomised controlled trial (n=128) aims to investigate the antidepressant efficacy of oral esketamine augmentation in patients with treatment-resistant major depressive disorder (TRD), who have not responded adequately to standard antidepressants.

Sponsored by UMCG and supported by ZonMW, the study seeks to assess changes in symptom severity using the Hamilton Depression Rating Scale (HDRS17), along with response rates and partial responses.

Secondary outcomes include various measures of depression severity, quality of life, and biomarkers, among others. The trial involves oral S-ketamine or placebo administration for 6 weeks, with follow-up assessments over a 10-week period.

Participants aged between 18 and 80, diagnosed with TRD, and currently on antidepressant medication will be recruited. Exclusion criteria cover factors such as comorbid psychiatric disorders and recent substance use. Recruitment is pending, with an anticipated start date of October 2016.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Netherlands
Visit trial
Status Planned
Results Published Yes
Start date 01 October 2016
End date 30 December 2024
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 128
Sex All
Age 18- 80
Therapy No

Trial Details

This double-blind, randomised controlled trial (n=128) investigates the antidepressant efficacy of oral S-ketamine augmentation in patients with treatment-resistant major depressive disorder (TRD). Participants, aged 18 to 80, diagnosed with TRD and currently on antidepressant medication, will be recruited. The trial involves oral S-ketamine or placebo administration for 6 weeks, with follow-up assessments over a 10-week period.

NCT Number NL6030

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.

Papers

Oral esketamine in patients with treatment-resistant depression: a double-blind, randomized, placebo-controlled trial with open-label extension
This randomized placebo-controlled trial (n=111) investigated the efficacy, safety, and tolerability of fixed low-dose oral esketamine (3x p/d 42d; 30-90mg; oral) in patients with treatment-resistant depression (TRD). Results indicate that fixed low-dose oral esketamine did not show benefit on depressive symptom severity compared to placebo, but individually titrated higher doses in the open-label extension phase demonstrated potential antidepressant properties.

Data attribution

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