ECT vs. Esketamine (ETES)

Medical University Innsbruck

Status and phase: Withdrawn; Phase 3

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Treatments: Drug: Esketamine nasal spray; Procedure: Electroconvulsive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04924257

1417/2020

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intranasal Esketamine

Experimental group

Treatment:

Drug: Esketamine nasal spray

ECT

Active Comparator group

Treatment:

Procedure: Electroconvulsive therapy