Overview
Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication (TCA) in the treatment of major depressive disorder (MDD) in the Netherlands.
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 (TCA). Reliable information on outcomes of ECT in comparison with TCA 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 (TCA) 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 (TCA) by determining the impact of treatment with ECT or TCA 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 (TCA group) 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.
Eligibility
Inclusion Criteria:
- adult patients (>18 years) with a major depressive disorder who will either start with ECT or TCA
- failed response to at least 1 adequate dose-duration trial with antidepressants
- moderate or severe depression (HDRS-17 >16)
Exclusion Criteria:
- lifetime diagnosis schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome
- the presence of a concurrent significant medical condition impeding the ability to participate