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ECT vs. Esketamine (ETES)

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder

Status
Withdrawn
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Esketamine nasal spray
Electroconvulsive therapy
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medical University Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intranasal Esketamine

ECT

Arm Description

Outcomes

Primary Outcome Measures

MADRS score
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

Secondary Outcome Measures

Full Information

First Posted
June 7, 2021
Last Updated
August 2, 2022
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT04924257
Brief Title
ECT vs. Esketamine
Acronym
ETES
Official Title
Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible participants
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Esketamine
Arm Type
Experimental
Arm Title
ECT
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Esketamine nasal spray
Intervention Description
Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS <10).
Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive therapy
Other Intervention Name(s)
ECT
Intervention Description
Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS <10).
Primary Outcome Measure Information:
Title
MADRS score
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). MADRS score ≥ 25 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). Age: 18 - 50 years Written informed consent Exclusion Criteria: Participation in another interventional clinical trial Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy: Patients who meet any exclusion criteria for nasal esketamine treatment as described in the clinical guidelines Contraindications to the conduction of MRI 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). history of ECT (unsuccessful or successful) suicidal tendency requiring admission in a locked ward pregnancy or lactation period lack of anesthetic clearance for any other reason insufficient command of German language.
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

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ECT vs. Esketamine

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