ECT vs. Esketamine

Phase 3

Withdrawn

• Conditions: Treatment Resistant Depression; Major Depressive Disorder
• Interventions: Drug: Esketamine nasal spray; Procedure: Electroconvulsive therapy

• Registration Number: NCT04924257
• Lead Sponsor: Medical University Innsbruck

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-11
• Study Start: 2021-07-28
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-05
• Primary Completion: 2023-08
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Esketamine	Esketamine nasal spray	-
ECT	Electroconvulsive therapy	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria