ECT vs. Esketamine | NCT04924257

Studies
ECT vs. Esketamine

NCT04924257

Sponsor

Medical University Innsbruck

Status

Withdrawn

Last Update Posted

Aug 5, 2022Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Treatment Resistant Depression
Major Depressive Disorder

Interventions

Esketamine nasal spray
Electroconvulsive therapy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No eligible participants

Expanded Access Info

Start Date

Jul 28, 2021Actual

Primary Completion Date

Aug 2023Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Jun 7, 2021

First Submission Date that Met QC Criteria

Jun 7, 2021

First Posted Date

Jun 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Intranasal Esketamine	Experimental		Drug: Esketamine nasal spray
ECT	Active Comparator		Procedure: Electroconvulsive therapy

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D061218	Depressive Disorder, Treatment-Resistant
D003865	Depressive Disorder, Major

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies
D004191	Behavioral Disciplines and Activities
D004597	Electroshock