ECT vs. Esketamine

Last updated: August 2, 2022
Sponsor: Medical University Innsbruck
Overall Status: Trial Not Available

Phase

3

Condition

Depression (Major/severe)

Affective Disorders

Depression (Adult And Geriatric)

Treatment

N/A

Clinical Study ID

NCT04924257
1417/2020
  • Ages 18-50
  • All Genders

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.

Eligibility Criteria

Inclusion

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 distinctlydifferent classes of antidepressants (≥ 4 weeks each)] (88).
  4. Age: 18 - 50 years
  5. Written informed consent

Exclusion

Exclusion Criteria:

  1. Participation in another interventional clinical trial
  2. Relative contraindications to ECT treatment in accordance with the consensus paper ofthe Austrian Society of Psychiatry and Psychotherapy:
  3. Patients who meet any exclusion criteria for nasal esketamine treatment as describedin 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).
  1. history of ECT (unsuccessful or successful)
  2. suicidal tendency requiring admission in a locked ward
  3. pregnancy or lactation period
  4. lack of anesthetic clearance for any other reason
  5. insufficient command of German language.

Study Design

Study Start date:
July 28, 2021
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • Medical University Innsbruck

    Innsbruck, Tyrol 6020
    Austria

    Site Not Available

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