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ECT vs. Esketamine

NCT04924257 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-08-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Esketamine nasal spray

Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS \<10).

PROCEDURE

Electroconvulsive therapy

Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS \<10).

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2023-08-31
Completion
2024-04-30

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924257 on ClinicalTrials.gov