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

Study Overview
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Brief Summary
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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.

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 (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.

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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Procedure: Electroconvulsive therapy (ECT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECT group<br>110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment | Procedure: Electroconvulsive therapy (ECT)<br>* ECT<br>|
| TCA group<br>110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication (TCA) as treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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) | Subjective Assessment of Memory Impairment (SAMI) | change from baseline at 3 months, 6 months and 12 months | 
| 15 words test (15WT) | (15WT; Saan & Deelman, 1986) | change from baseline at 3 months, 6 months and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive disorder, ECT, Electroconvulsive therapy, TCA, Cost-effectiveness