ECT vs. Esketamine

Major Depressive Disorder Clinical Trial

— ETES  

Official title:

Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04924257
• Other study ID #: 1417/2020
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 28, 2021
• Est. completion date: April 2024

Study information

• Verified date: June 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Treatment Resistant Depression

Intervention

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).

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

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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