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

Phase 1

• Conditions: treatment resistant depression; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-004172-17-AT
• Lead Sponsor: Medizinische Universität Innsbruck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-23
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 (< 4 weeks each)]
4. Age: 18 - 50 years
5. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified