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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04924257
Other study ID # 1417/2020
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date July 28, 2021
Est. completion date April 2024

Study information

Verified date June 2021
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Esketamine nasal spray
Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS <10).
Procedure:
Electroconvulsive therapy
Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS <10).

Locations

Country Name City State
Austria Medical University Innsbruck Innsbruck Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary MADRS score Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as >50% reduction in score 4 weeks
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