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

Depressive Disorder, Major Clinical Trial

— PROSPECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306184
• Other study ID #: 2021-13224
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Radboud University Medical Center
• Contact: Philip van Eijndhoven, PhD, MD
• Phone: 243611111
• Email: philip.vaneijndhoven[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Procedure:
• Electroconvulsive therapy (ECT)
ECT

Locations

Country	Name	City	State
Netherlands	GGz inGeest	Amsterdam
Netherlands	RadboudUMC	Nijmegen

Sponsors (6)

Lead Sponsor	Collaborator
Radboud University Medical Center	Canisius-Wilhelmina Hospital, ETZ, GGZ inGeest, St. Antonius Hospital, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of treatment as measured by reduction on HDRS-17	Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)	change from baseline at 3 months, 6 months and 12 months
Secondary	Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)	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
Secondary	Quality of life as measured with the EuroQol-5D (EQ-5D-5L)	Quality of life as measured with the EuroQol-5D (EQ-5D-5L)	change from baseline at 3 months, 6 months and 12 months
Secondary	Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)	Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)	change from baseline at 3 months, 6 months and 12 months
Secondary	COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)		change from baseline at 3 months, 6 months and 12 months
Secondary	Subjective Assessment of Memory Impairment (SAMI)	Subjective Assessment of Memory Impairment (SAMI)	change from baseline at 3 months, 6 months and 12 months
Secondary	15 words test (15WT)	(15WT; Saan & Deelman, 1986)	change from baseline at 3 months, 6 months and 12 months
Secondary	Verbal fluency test (e.g., Lezak et al., 2012).	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).	change from baseline at 3 months, 6 months and 12 months