ECT vs. Esketamine

NCT ID: NCT04924257

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intranasal Esketamine

Group Type: EXPERIMENTAL

Esketamine nasal spray

Intervention Type: DRUG

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

ECT

Group Type: ACTIVE_COMPARATOR

Electroconvulsive therapy

Intervention Type: PROCEDURE

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

Interventions

Esketamine nasal spray

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

Intervention Type: DRUG

Electroconvulsive therapy

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

Intervention Type: PROCEDURE

Other Intervention Names

ECT

Eligibility Criteria

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

Other Identifiers

1417/2020

Identifier Type: -

Identifier Source: org_study_id