Comparison of effectiveness of Electroconvulsive Therapy and Esketamine nasal spray in patients with depression

Electroconvulsive therapy vs. esketamine nasal spray in treatment-resistant depression: a longitudinal, randomized efficacy comparison pilot study - ETES

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004172-17-AT

Enrollment

Registered

2021-03-23

Start date

2021-04-26

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

treatment resistant depression

Interventions

Trade Name: Spravato Pharmaceutical Form: Nasal spray INN or Proposed INN: esketamine Other descriptive name: ESKETAMINE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion 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 SCID-5-CV Interview 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 (=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Participation in another interventional clinical trial 2. Relative contraindications to ECT treatment: Neurodegenerative disease e.g. stroke, epilepsy, severe traumatic brain injury, intracranial aneurysm (>7 mm) except small meningioma; acute cardiac disease (<3 months) or chronic heart disease; not organized deep venous thrombosis; autoimmune disease with brain involvement; pheochromocytoma; ablatio retinae; family anamnesis for epilepsy; other clinical contraindications 3. Patients who meet any exclusion criteria for nasal esketamine treatment: Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation; history of intracerebral hemorrhage; hypersensitivity to esketamine, ketamine, or any of the excipients. 4. Contraindications to the conduction of MRI: claustrophobia; metal, electric, magnetic, or mechanically driven implants; tattoos on head or neck 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 ideation 8. pregnancy or lactation period 9. lack of anesthetic clearance for any other reason 10. insufficient command of German language.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effectiveness of electroconvulsive therapy (ECT) vs. esketamine nasal spray using the Montgomery Asberg Depression Rating Scale (MADRS);Secondary Objective: - brain function and structure in patients with TRD (pretreatment) - the cognitive effects of ECT and intranasal esketamine - the short- and medium-term effects of ECT and intranasal esketamine on functional and structural connectivity in patients with TRD - the effects of ECT and intranasal esketamine on working memory and on social cognition on behavioral and functional level in TRD - correlations between clinical effects and possible changes in task-related functional activity as well as functional and structural connectivity longitudinally - possible imaging biomarkers that predict clinical response to ECT or intranasal esketamine. ;Primary end point(s): Effect of treatment (ECT vs. esketamine) on the course of treatment resistant depression measured by the MADRS score;Timepoint(s) of evaluation of this end point: Visit 1, week 1-4, EOF-Visit, FU-Visit	—

Measure

Time frame

Main Objective: To compare the effectiveness of electroconvulsive therapy (ECT) vs. esketamine nasal spray using the Montgomery Asberg Depression Rating Scale (MADRS);Secondary Objective: - brain function and structure in patients with TRD (pretreatment) - the cognitive effects of ECT and intranasal esketamine - the short- and medium-term effects of ECT and intranasal esketamine on functional and structural connectivity in patients with TRD - the effects of ECT and intranasal esketamine on working memory and on social cognition on behavioral and functional level in TRD - correlations between clinical effects and possible changes in task-related functional activity as well as functional and structural connectivity longitudinally - possible imaging biomarkers that predict clinical response to ECT or intranasal esketamine. ;Primary end point(s): Effect of treatment (ECT vs. esketamine) on the course of treatment resistant depression measured by the MADRS score;Timepoint(s) of evaluation of this end point: Visit 1, week 1-4, EOF-Visit, FU-Visit

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: End of clinical trial ;Secondary end point(s): -Short- and medium-term changes in the functional (rs-fMRI) and structural (DTI) connectivity after treatment - Effects of the two treatment arms on working memory (n-back) and social cognition (eStroop) - To find possible imaging biomarkers that predict clinical response to ECT or intranasal esketamine	—

Countries

Austria

Contacts

Public ContactKompetenzzentrum klinische Studien

Medizinische Universität Innsbruck

kks-regulatory@i-med.ac.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026