ECT vs. Esketamine

NCT04924257 | Withdrawn Phase 3

• 1 other identifier: 1417/2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Study Arms (2)

Intranasal Esketamine

EXPERIMENTAL

Drug: Esketamine nasal spray

ECT

ACTIVE COMPARATOR

Procedure: Electroconvulsive therapy

Interventions

Esketamine nasal spray DRUG

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

Intranasal Esketamine

Electroconvulsive therapy PROCEDURE

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

Also known as: ECT

ECT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: July 28, 2021
• Primary Completion: August 1, 2023
• Study Completion: April 1, 2024
• Last Updated: August 5, 2022

Record last verified: 2021-06

Locations

AU (1)