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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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

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Depressive Disorder, Major

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ECT group

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

Electroconvulsive therapy (ECT)

Intervention Type PROCEDURE

ECT

Medication group

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

No interventions assigned to this group

Interventions

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Electroconvulsive therapy (ECT)

ECT

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No