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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05306184

Collaborator

GGzInGeest (Other), Parnassia Groep (Other), UMC Utrecht (Other), St. Antonius ziekenhuis (Other)

220

Enrollment

Locations

Anticipated Duration (Months)

110

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Procedure: Electroconvulsive therapy (ECT)

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 (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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

220 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
ECT group 110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment	Procedure: Electroconvulsive therapy (ECT) ECT
TCA group 110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication (TCA) as treatment

Arm

Intervention/Treatment

ECT group

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

Procedure: Electroconvulsive therapy (ECT)

ECT

TCA group

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

Outcome Measures

Primary Outcome Measures

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

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)
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)
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)
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)
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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