NCT05306184

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
PROCEDURE	Electroconvulsive therapy (ECT)	ECT

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-04-01
• Last updated: 2024-04-12

Locations

2 sites across 1 country: Netherlands