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Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA — PROSPECT  

Depressive Disorder, Major Clinical Trial

Official title:
Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA

Clinical Trial Summary

Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.

Clinical Trial Description

Rationale: Currently, detailed information on the cost-effectiveness of ECT based on real-world data is lacking, as well as the comparative cost-effectiveness with respect to medication. Reliable information on outcomes of ECT in comparison with antidepressant treatment and its cognitive side-effects is needed for patients and clinicians to make a balanced and shared decision regarding choosing or refraining from ECT. Objective: Primary Objective: determine (cost)-effectiveness of ECT compared to medication by determining the impact of treatment for MDD with ECT or TCA on remission rates using a one-year time horizon (trial-based economic evaluation) Secondary Objective: determine side-effects of ECT compared to medication by determining the impact of treatment with ECT or medication on side-effects and quality of life during a one-year follow-up Study design: Observational, parallel inception cohort study of patients who will undergo standard clinical care according to current guidelines. Study population: 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT (ECT group) and 110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will undergo treatment with antidepressants will be recruited from specialized clinics (academic hospital, general hospital and GGz-institute) and followed-up for one year to gather reliable data on efficacy including relapse rates, cost-effectiveness, quality of life and cognitive functioning. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05306184
Study type Observational
Source Radboud University Medical Center
Contact Philip van Eijndhoven, PhD, MD
Phone 243611111
Email philip.vaneijndhoven@radboudumc.nl
Status Recruiting
Phase
Start date January 1, 2022
Completion date December 31, 2025
View Details
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