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

Radboud University Medical Center

Status: Enrolling

Conditions: Depressive Disorder, Major

Treatments: Procedure: Electroconvulsive therapy (ECT)

Study type: Observational

Funder types: Other

Identifiers

NCT05306184

2021-13224

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients (>18 years) with a major depressive disorder who will either start with ECT or medication
• 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

Trial design

220 participants in 2 patient groups

ECT group

Description:

110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment

Treatment:

Procedure: Electroconvulsive therapy (ECT)

Medication group

Description:

110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication as treatment