ECT vs. Esketamine

This longitudinal, randomized controlled trial (n=0, withdrawn) compares the efficacy of Electroconvulsive Therapy (ECT) and intranasal esketamine in patients with Treatment-Resistant Depression (TRD).

While ECT is currently the most effective treatment for TRD, intranasal esketamine has emerged as a rapid-acting antidepressant. The study aims to fill the gap in understanding the exact position of esketamine in treatment algorithms for TRD by comparing its efficacy with ECT. Additionally, the effects of both treatments on brain connectivity and structure will be measured using functional magnetic resonance imaging (fMRI).

Inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomised to receive either ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be assessed using fMRI.

The study started on July 28, 2021, and is estimated to be completed by April 2024. Austria, Tyrol Locations, specifically Innsbruck, Tyrol, is where the study is being conducted.

Eligible participants must be aged between 18 to 50 years and have a DSM-5 diagnosis of Major Depressive Disorder without psychotic features. They should also have a MADRS score of ≥ 25 and be pharmacologically treatment-resistant. The study’s primary outcome measure is the reduction of Montgomery-Asberg Depression Rating Scale (MADRS) score after four weeks. The trial’s sponsor is the Medical University Innsbruck.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Austria
Visit trial
Status Withdrawn
Results Published No
Start date 28 July 2021
End date 30 April 2024
Phase Phase III
Design Open
Type Interventional
Generation Second
Participants 0
Sex All
Age 18- 50
Therapy Yes

Trial Details

Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide. Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms. To the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI). In this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI.

NCT Number NCT04924257

Data attribution

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