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

Recruiting

• Conditions: Depressive Disorder, Major
• Interventions: Procedure: Electroconvulsive therapy (ECT)

• Registration Number: NCT05306184
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECT group	Electroconvulsive therapy (ECT)	110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment

Primary Outcome Measures

Name	Time	Method
Effectiveness of treatment as measured by reduction on HDRS-17	change from baseline at 3 months, 6 months and 12 months	Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)

Secondary Outcome Measures

Name	Time	Method
Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)	change from baseline at 3 months, 6 months and 12 months	Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)	change from baseline at 3 months, 6 months and 12 months	Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)	change from baseline at 3 months, 6 months and 12 months
Subjective Assessment of Memory Impairment (SAMI)	change from baseline at 3 months, 6 months and 12 months	Subjective Assessment of Memory Impairment (SAMI)
Quality of life as measured with the EuroQol-5D (EQ-5D-5L)	change from baseline at 3 months, 6 months and 12 months	Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
15 words test (15WT)	change from baseline at 3 months, 6 months and 12 months	(15WT; Saan \& Deelman, 1986)
Verbal fluency test (e.g., Lezak et al., 2012).	change from baseline at 3 months, 6 months and 12 months	It typically consists of two tasks: category fluency (sometimes called semantic fluency; Benton, 1968) and letter fluency (sometimes called phonemic fluency; Newcombe, 1969). participants are given 1 min to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency).

Trial Locations

Locations (2)

GGz inGeest; 🇳🇱 Amsterdam, Netherlands

RadboudUMC; 🇳🇱 Nijmegen, Netherlands