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PRediction Of Treatment Response to ECT in Depression and Cognitive Side effecTs (PROTECT)

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ClinicalTrials.gov Identifier: NCT02562846
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Linda van Diermen, Universiteit Antwerpen

Brief 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 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.


Condition or disease Intervention/treatment
Depression Other: Psychological testing and biological sample collection

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Study Type : Observational [Patient Registry]
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Prediction of ECT Treatment Response in Depression and Early Detection of ECT-related Memory Problems
Study Start Date : June 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ECT patients
Depressive patients receiving electroconvulsive therapy.
Other: Psychological testing and biological sample collection
For this study, there will be psychological tests, blood and hair sample collections, and part of the patients will undergo an MRI.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562846


Locations
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Belgium
PZ Duffel
Duffel, Antwerp, Belgium, 2570
Sponsors and Collaborators
Universiteit Antwerpen
Investigators
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Study Director: Bernard Sabbe, MD, prof. Duffel Psychiatric Hospital

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Linda van Diermen, Dr., Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02562846     History of Changes
Other Study ID Numbers: B300201524466
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Linda van Diermen, Universiteit Antwerpen:
electroconvulsive therapy
response prediction
cognitive side effects

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders