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ETES: ECT vs. Esketamine

Sponsor
Medical University Innsbruck (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04924257
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
32.1
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Esketamine nasal spray
  • Procedure: Electroconvulsive therapy
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
Actual Study Start Date :
Jul 28, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intranasal Esketamine

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).
Active Comparator: ECT

Procedure: Electroconvulsive therapy
Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS <10).
Other Names:
  • ECT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MADRS score [4 weeks]

      Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as >50% reduction in score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Innsbruck Innsbruck Tyrol Austria 6020

    Sponsors and Collaborators

    • Medical University Innsbruck

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University Innsbruck
    ClinicalTrials.gov Identifier:
    NCT04924257
    Other Study ID Numbers:
    • 1417/2020
    First Posted:
    Jun 11, 2021
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Depressive Disorder, Major
    Depressive Disorder, Treatment-Resistant
    Esketamine

    Study Results

    No Results Posted as of Aug 5, 2022