NCT05306184

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 20, 2022

Last Update Submit

April 16, 2026

Conditions

Depressive Disorder, Major

Keywords

Depressive disorderECTElectroconvulsive therapyAntidepressantsCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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)

    change from baseline at 3 months, 6 months and 12 months

  • 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)

    change from baseline at 3 months, 6 months and 12 months

  • +2 more secondary outcomes

Study Arms (2)

ECT group

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

Procedure: Electroconvulsive therapy (ECT)

Medication group

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

Interventions

Electroconvulsive therapy (ECT)PROCEDURE

ECT

ECT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GGz inGeest

Amsterdam, Netherlands

Location

RadboudUMC

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Convulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Philip van Eijndhoven, PhD, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 1, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)