WithdrawnPhase 3

ECT vs. Esketamine

NCT04924257 · ETES · Medical University Innsbruck

Closed to entry

Status

Not accepting participants

Phase 3

Phase

—

Target enrolment

Study sites

Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

MADRS score
Measured over 4 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 50 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: 1. DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the Structured Clinical Interview for the DSM-V (SCID-V). 2. MADRS score ≥ 25 3. Pharmacologically treatment-resistant depressive episode \[Stage ≥ II, defined by Thase \& Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (≥ 4 weeks each)\] (88). 4. Age: 18 - 50 years 5. Written informed consent Exclusion Criteria: 1. Participation in another interventional clinical trial 2. Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy: 3. Patients who meet any exclusion criteria for nasal esketamine treatment as described in the clinical guidelines 4. Contraindications to the conduction of MRI 5. History of one or more of the following diagnoses (DSM-5): * MDD, single or recurrent episode with psychotic features (296.24; 296.34) * past or current substance dependence (except caffeine, nicotine) (303.x, 304.x, 305.x) * neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x) * schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x) * neurocognitive disorders (290.x, 292.x, 294.x, 331.x). 6. history of ECT (unsuccessful or successful) 7. suicidal tendency requiring admission in a locked ward 8. pregnancy or lactation period 9. lack of anesthetic clearance for any other reason 10. insufficient command of German language.

Where

1 study site

Facility	City	Region	Country
Medical University Innsbruck	Innsbruck	Tyrol	Austria

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04924257 on ClinicalTrials.gov →

Last updated in the registry 2022-08-05. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication