Clinical trial NCT05306184: Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA
Official title: Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Disorder, Major
Keywords: Depressive disorder
ECT
Electroconvulsive therapy
Antidepressants
Cost-effectiveness
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: GGZ inGeest
name: Canisius-Wilhelmina Hospital
name: UMC Utrecht
name: St. Antonius Hospital
name: ETZ
First posted: 2022-04-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of treatment as measured by reduction on HDRS-17
timeFrame: change from baseline at 3 months, 6 months and 12 months
Secondary outcomes:
measure: Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
timeFrame: change from baseline at 3 months, 6 months and 12 months
measure: Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
timeFrame: change from baseline at 3 months, 6 months and 12 months
measure: Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
timeFrame: change from baseline at 3 months, 6 months and 12 months
measure: COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)
timeFrame: change from baseline at 3 months, 6 months and 12 months
measure: Subjective Assessment of Memory Impairment (SAMI)
timeFrame: change from baseline at 3 months, 6 months and 12 months
measure: 15 words test (15WT)
timeFrame: change from baseline at 3 months, 6 months and 12 months
measure: Verbal fluency test (e.g., Lezak et al., 2012).
timeFrame: change from baseline at 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: GGz inGeest
city: Nijmegen
country: Netherlands
facility: RadboudUMC
Study officials:
affiliation: Radboud University Medical Center
name: Philip van Eijndhoven, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: