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

April 30, 2018 updated by: Linda van Diermen, Universiteit Antwerpen

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Duffel, Antwerp, Belgium, 2570
        • Pz Duffel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Investigators

  • Study Director: Bernard Sabbe, MD, prof., Duffel Psychiatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201524466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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