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| Name | Class |
|---|---|
| GGZ inGeest | OTHER |
| Canisius-Wilhelmina Hospital | OTHER |
| UMC Utrecht | OTHER |
| St. Antonius Hospital |
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Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECT group | 110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment |
| |
| Medication group | 110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication as treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive therapy (ECT) | Procedure | ECT |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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110 patients (>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT 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 and quality of life.
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| Name | Affiliation | Role |
|---|---|---|
| Philip van Eijndhoven, PhD, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GGz inGeest | Amsterdam | Netherlands | ||||
| RadboudUMC |
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| Label | URL |
|---|---|
| Protocol Paper PET project | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004565 | Electroconvulsive Therapy |
| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
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| OTHER |
| Parnassia | UNKNOWN |
| Elisabeth-TweeSteden Ziekenhuis | OTHER |
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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 |
| Nijmegen |
| Netherlands |
| D011580 | Psychological Techniques |