Clinical trial NCT04924257: ECT vs. Esketamine
Official title: Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Treatment Resistant Depression
Major Depressive Disorder
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:
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.

Primary outcomes:
measure: MADRS score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
References: