Depressive Disorder, MajorPROSPECTNCT05306184
Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA
An observational study of Depressive Disorder, Major, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Electroconvulsive therapy (ECT)
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Electroconvulsive therapy (ECT)
- Keywords
- Depressive disorder, ECT, Electroconvulsive therapy, Antidepressants, Cost-effectiveness
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapy (ECT)Procedure or surgery
ECT
| Study group | Role | What they receive |
|---|---|---|
| ECT group | 110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment Receives: Procedure: Electroconvulsive therapy (ECT) | |
| Medication group | 110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication as treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of treatment as measured by reduction on HDRS-17
Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)
Measured: 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)
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
Measured: 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)
Measured: 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)
Measured: change from baseline at 3 months, 6 months and 12 months
COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)
Measured: change from baseline at 3 months, 6 months and 12 months
Subjective Assessment of Memory Impairment (SAMI)
Subjective Assessment of Memory Impairment (SAMI)
Measured: change from baseline at 3 months, 6 months and 12 months
15 words test (15WT)
(15WT; Saan \& Deelman, 1986)
Measured: 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).
Measured: change from baseline at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GGZ inGeest, Canisius-Wilhelmina Hospital, UMC Utrecht, St. Antonius Hospital, Parnassia, Elisabeth-TweeSteden Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Philip van Eijndhoven, PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306184
- Sponsor's protocol ID
- 2021-13224
- Acronym
- PROSPECT
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA
- ClinicalTrials.gov ID
- NCT05306184
- Acronym / sponsor ID
- PROSPECT / 2021-13224
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive disorder, ECT, Electroconvulsive therapy, Antidepressants, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- GGZ inGeest, Canisius-Wilhelmina Hospital, UMC Utrecht, St. Antonius Hospital, Parnassia, Elisabeth-TweeSteden Ziekenhuis
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT group | – | Procedure: Electroconvulsive therapy (ECT)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapy (ECT)ECT | Procedure or surgery | ECT group |
Primary outcome
Effectiveness of treatment as measured by reduction on HDRS-17
Time frame: 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)
7 secondary outcomes
Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)
Time frame: change from baseline at 3 months, 6 months and 12 months
Quality of life as measured with the EuroQol-5D (EQ-5D-5L)
Time frame: change from baseline at 3 months, 6 months and 12 months
Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)
Time frame: change from baseline at 3 months, 6 months and 12 months
COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)
Time frame: change from baseline at 3 months, 6 months and 12 months
Subjective Assessment of Memory Impairment (SAMI)
Time frame: change from baseline at 3 months, 6 months and 12 months
15 words test (15WT)
Time frame: change from baseline at 3 months, 6 months and 12 months
Verbal fluency test (e.g., Lezak et al., 2012).
Time frame: change from baseline at 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Protocol Paper PET projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip van Eijndhoven, PhD, MD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of treatment as measured by reduction on HDRS-17 (time frame: change from baseline at 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.