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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PZ Duffel

Duffel, Antwerp, 2570, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychological testing and biological sample collection

Other

For this study, there will be psychological tests, blood and hair sample collections, and part of the patients will undergo an MRI.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

Prediction of ECT Treatment Response in Depression and Early Detection of ECT-related Memory Problems

Acronym: PROTECT

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Sep 29, 2015
Registry last updated: May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed