Depressive Disorder, Major
Conditions
Keywords
Depressive disorder, ECT, Electroconvulsive therapy, Antidepressants, Cost-effectiveness
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.
Interventions
PROCEDUREElectroconvulsive therapy (ECT)
ECT
Sponsors
GGZ inGeest
Canisius-Wilhelmina Hospital
UMC Utrecht
St. Antonius Hospital
ETZ
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) |
| 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). |
| Subjective Assessment of Memory Impairment (SAMI) | change from baseline at 3 months, 6 months and 12 months | Subjective Assessment of Memory Impairment (SAMI) |
Countries
Netherlands
Contacts
Primary ContactPhilip van Eijndhoven, PhD, MD
Backup ContactJordy Rovers, MD
Outcome results
None listed