DepressionPROTECTNCT02562846
PRediction Of Treatment Response to ECT in Depression and Cognitive Side effecTs
An observational study of Depression, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
It has been convincingly demonstrated that electroconvulsive therapy (ECT) works better and sooner than antidepressants in the treatment of certain subtypes of depression. Given this effectiveness, it would be unfortunate not to give ECT to patients with good response chances as this could substantially shorten the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Psychological testing and biological sample collection
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2015to 28 Feb 2018
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators include a severely depressed patient population that has to be evaluated regularly. For that reason, the investigators choose residential patients. They are recruited at the psychiatric hospital in Duffel. Treating psychiatrists consider a candidate eligible for ECT and start pre-ECT investigations. The investigators screen all depressive ECT patients for inclusion in the study and ask for their informed consent (IC). The treating psychiatrist decides when ECT is stopped considering clinical evolution and side effects.
Who may be able to join
- Admitted to PZ Duffel and eligible for ECT because of major depressive disorder of major depressive episode in bipolar disorder (according to DSM-5 criteria).
- Score on HDRS ≥ 17.
- Have signed an IC form indicating that they understand the purpose of and procedures required for the study and are willing to participate in this study. In case of incapacity, a close relative will be asked to give informed consent.
- Be medically stable on the basis of physical examination and vital signs performed during the pre-ECT screening procedure.
Who cannot join
- Drug or alcohol dependence as detected in the MINI interview at screening (<6 months before ECT).
- Primary psychotic disorder according to DSM-5 criteria (<6 months before ECT).
- Is currently enrolled in a study with an investigational study drug.
- Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of ECT Treatment Response in Depression and Early Detection of ECT-related Memory Problems
It has been convincingly demonstrated that electroconvulsive therapy (ECT) works better and sooner than antidepressants in the treatment of certain subtypes of depression. Given this effectiveness, it would be unfortunate not to give ECT to patients with good response chances as this could substantially shorten the length of a severe depressive episode. Instead of going through all possible psychopharmacological treatment steps, ECT could be proposed much earlier as a treatment option for those patients who might have good response chances. This would be a great advantage for the severely depressed patient, with a decreased disease-burden and hospitalization duration.
However, up to now, objective and reliable predictive factors for good ECT response have not yet been established. Clinical characteristics such as psychomotor retardation, psychotic features and age have often been used to predict the outcome of ECT, but there is too little evidence to consider these as strong predictive factors.
Read more
The current project is designed to allow better prediction of ECT-response. The investgators base their selection of predictors on clinical impression and previous research results. The predictive capacity of psychomotor functioning, psychotic symptoms and several biomarkers will be investigated. With these clinical and biological patient and depression characteristics, the investigators aim to develop a decision making tool that will allow a more accurate indication of ECT.
The investigators also investigate ways to predict whether or not a patient will have a good response when treatment has already started, based on an early improvement of psychomotor functioning.
Another subject of great importance is predicting and preventing side-effects. When patients at risk for lasting cognitive side-effects can be identified early in the treatment course, treatment can be adjusted to prevent persistence of memory problems. Therefore, the second part of the study focuses on identifying people at risk for cognitive side effects early in the treatment course.
- Conditions
- Depression
- Being tested
- Psychological testing and biological sample collection
- Keywords
- electroconvulsive therapy, response prediction, cognitive side effects
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological testing and biological sample collectionOther
For this study, there will be psychological tests, blood and hair sample collections, and part of the patients will undergo an MRI.
| Study group | Role | What they receive |
|---|---|---|
| ECT patients | Depressive patients receiving electroconvulsive therapy. Receives: Other: Psychological testing and biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS)
The HDRS is one of the most commonly used instruments for assessing depression. It is a valid and reliable clinician-rated measure that has been used extensively in clinical research and in clinical practice for assessment of the severity of depression, changes in its severity over time and efficacy of treatment.
Measured: Baseline measurement before the first electroshock, compared with final HDRS score measured after the last electroshock of the acute ECT course. The duration between the measurement before and after ECT will be between 3-9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJun 2015
- Primary completion30 Sep 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- 74 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda van Diermen, Universiteit Antwerpen
- Investigators
- Bernard Sabbe, MD, prof., Study director, Duffel Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562846
- Sponsor's protocol ID
- B300201524466
- Acronym
- PROTECT
- Status last verified
- Apr 2018
- First submitted
- 26 Aug 2015
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
van Diermen L, Poljac E, Van der Mast R, Plasmans K, Van den Ameele S, Heijnen W, Birkenhager T, Schrijvers D, Kamperman A. Toward Targeted ECT: The Interdependence of Predictors of Treatment Response in Depression Further Explained. J Clin Psychiatry. 2020 Dec 15;82(1):20m13287. doi: 10.4088/JCP.20m13287.
PubMed 33326710Hebbrecht K, Giltay EJ, Birkenhager TK, Sabbe B, Verwijk E, Obbels J, Roelant E, Schrijvers D, Van Diermen L. Cognitive change after electroconvulsive therapy in mood disorders measured with the Montreal Cognitive Assessment. Acta Psychiatr Scand. 2020 Nov;142(5):413-422. doi: 10.1111/acps.13231. Epub 2020 Sep 21.
PubMed 32895922Baeten RF, Van Rossum EFC, De Rijke YB, Sabbe BGC, Van Der Mast RC, Belge JB, Fransen E, Schrijvers DL, Birkenhager TK, Van Diermen L. Hair cortisol in patients with a depressive episode treated with electroconvulsive therapy. J Affect Disord. 2020 Sep 1;274:784-791. doi: 10.1016/j.jad.2020.05.042. Epub 2020 May 28.
PubMed 32664015Belge JB, Van Diermen L, Schrijvers D, Sabbe B, Constant E, de Timary P, De Keyzer S, Parizel P, Vansteelandt K, Sienaert P, van Eijndhoven P. The basal ganglia: A central hub for the psychomotor effects of electroconvulsive therapy. J Affect Disord. 2020 Mar 15;265:239-246. doi: 10.1016/j.jad.2020.01.033. Epub 2020 Jan 13.
PubMed 32090747van Diermen L, Versyck P, van den Ameele S, Madani Y, Vermeulen T, Fransen E, Sabbe BGC, van der Mast RC, Birkenhager TK, Schrijvers D. Performance of the Psychotic Depression Assessment Scale as a Predictor of ECT Outcome. J ECT. 2019 Dec;35(4):238-244. doi: 10.1097/YCT.0000000000000610.
PubMed 31764446van Diermen L, Hebbrecht K, Schrijvers D, Sabbe BCG, Fransen E, Birkenhager TK. The Maudsley Staging Method as predictor of electroconvulsive therapy effectiveness in depression. Acta Psychiatr Scand. 2018 Dec;138(6):605-614. doi: 10.1111/acps.12962. Epub 2018 Oct 1.
PubMed 30270433
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of ECT Treatment Response in Depression and Early Detection of ECT-related Memory Problems
- ClinicalTrials.gov ID
- NCT02562846
- Acronym / sponsor ID
- PROTECT / B300201524466
- Conditions
- Depression
- Keywords
- electroconvulsive therapy, response prediction, cognitive side effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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.
It has been convincingly demonstrated that electroconvulsive therapy (ECT) works better and sooner than antidepressants in the treatment of certain subtypes of depression. Given this effectiveness, it would be unfortunate not to give ECT to patients with good response chances as this could substantially shorten the length of a severe depressive episode. Instead of going through all possible psychopharmacological treatment steps, ECT could be proposed much earlier as a treatment option for those patients who might have good response chances. This would be a great advantage for the severely depressed patient, with a decreased disease-burden and hospitalization duration.
However, up to now, objective and reliable predictive factors for good ECT response have not yet been established. Clinical characteristics such as psychomotor retardation, psychotic features and age have often been used to predict the outcome of ECT, but there is too little evidence to consider these as strong predictive factors.
The current project is designed to allow better prediction of ECT-response. The investgators base their selection of predictors on clinical impression and previous research results. The predictive capacity of psychomotor functioning, psychotic symptoms and several biomarkers will be investigated. With these clinical and biological patient and depression characteristics, the investigators aim to develop a decision making tool that will allow a more accurate indication of ECT.
The investigators also investigate ways to predict whether or not a patient will have a good response when treatment has already started, based on an early improvement of psychomotor functioning.
Another subject of great importance is predicting and preventing side-effects. When patients at risk for lasting cognitive side-effects can be identified early in the treatment course, treatment can be adjusted to prevent persistence of memory problems. Therefore, the second part of the study focuses on identifying people at risk for cognitive side effects early in the treatment course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT patients | – | Other: Psychological testing and biological sample collectionDepressive patients receiving electroconvulsive therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators include a severely depressed patient population that has to be evaluated regularly. For that reason, the investigators choose residential patients. They are recruited at the psychiatric hospital in Duffel. Treating psychiatrists consider a candidate eligible for ECT and start pre-ECT investigations. The investigators screen all depressive ECT patients for inclusion in the study and ask for their informed consent (IC). The treating psychiatrist decides when ECT is stopped considering clinical evolution and side effects.
Key inclusion criteria (4 listed)
- Admitted to PZ Duffel and eligible for ECT because of major depressive disorder of major depressive episode in bipolar disorder (according to DSM-5 criteria).
- Score on HDRS ≥ 17.
- Have signed an IC form indicating that they understand the purpose of and procedures required for the study and are willing to participate in this study. In case of incapacity, a close relative will be asked to give informed consent.
- Be medically stable on the basis of physical examination and vital signs performed during the pre-ECT screening procedure.
Key exclusion criteria (4 listed)
- Drug or alcohol dependence as detected in the MINI interview at screening (<6 months before ECT).
- Primary psychotic disorder according to DSM-5 criteria (<6 months before ECT).
- Is currently enrolled in a study with an investigational study drug.
- Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements.
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 |
|---|---|---|
| Psychological testing and biological sample collectionFor this study, there will be psychological tests, blood and hair sample collections, and part of the patients will undergo an MRI. | Other | ECT patients |
Primary outcome
Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline measurement before the first electroshock, compared with final HDRS score measured after the last electroshock of the acute ECT course. The duration between the measurement before and after ECT will be between 3-9 weeks.
The HDRS is one of the most commonly used instruments for assessing depression. It is a valid and reliable clinician-rated measure that has been used extensively in clinical research and in clinical practice for assessment of the severity of depression, changes in its severity over time and efficacy of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Derived from this study: PubMed 33326710van Diermen L, Poljac E, Van der Mast R, Plasmans K, Van den Ameele S, Heijnen W, Birkenhager T, Schrijvers D, Kamperman A. Toward Targeted ECT: The Interdependence of Predictors of Treatment Response in Depression Further Explained. J Clin Psychiatry. 2020 Dec 15;82(1):20m13287. doi: 10.4088/JCP.20m13287.
- Derived from this study: PubMed 32895922Hebbrecht K, Giltay EJ, Birkenhager TK, Sabbe B, Verwijk E, Obbels J, Roelant E, Schrijvers D, Van Diermen L. Cognitive change after electroconvulsive therapy in mood disorders measured with the Montreal Cognitive Assessment. Acta Psychiatr Scand. 2020 Nov;142(5):413-422. doi: 10.1111/acps.13231. Epub 2020 Sep 21.
- Derived from this study: PubMed 32664015Baeten RF, Van Rossum EFC, De Rijke YB, Sabbe BGC, Van Der Mast RC, Belge JB, Fransen E, Schrijvers DL, Birkenhager TK, Van Diermen L. Hair cortisol in patients with a depressive episode treated with electroconvulsive therapy. J Affect Disord. 2020 Sep 1;274:784-791. doi: 10.1016/j.jad.2020.05.042. Epub 2020 May 28.
- Derived from this study: PubMed 32090747Belge JB, Van Diermen L, Schrijvers D, Sabbe B, Constant E, de Timary P, De Keyzer S, Parizel P, Vansteelandt K, Sienaert P, van Eijndhoven P. The basal ganglia: A central hub for the psychomotor effects of electroconvulsive therapy. J Affect Disord. 2020 Mar 15;265:239-246. doi: 10.1016/j.jad.2020.01.033. Epub 2020 Jan 13.
- Derived from this study: PubMed 31764446van Diermen L, Versyck P, van den Ameele S, Madani Y, Vermeulen T, Fransen E, Sabbe BGC, van der Mast RC, Birkenhager TK, Schrijvers D. Performance of the Psychotic Depression Assessment Scale as a Predictor of ECT Outcome. J ECT. 2019 Dec;35(4):238-244. doi: 10.1097/YCT.0000000000000610.
- Derived from this study: PubMed 30270433van Diermen L, Hebbrecht K, Schrijvers D, Sabbe BCG, Fransen E, Birkenhager TK. The Maudsley Staging Method as predictor of electroconvulsive therapy effectiveness in depression. Acta Psychiatr Scand. 2018 Dec;138(6):605-614. doi: 10.1111/acps.12962. Epub 2018 Oct 1.
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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.
Bernard Sabbe, MD, prof. study director
Duffel Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Universiteit Antwerpen at 1 site in Belgium.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS) (time frame: Baseline measurement before the first electroshock, compared with final HDRS score measured after the last electroshock of the acute ECT course. The duration between the measurement before and after ECT will be between 3-9 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02562846, which also lists 6 linked publications.
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 1 May 2018.