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

Depression Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562846
• Other study ID #: B300201524466
• Status: Completed
• Start date: June 2015
• Est. completion date: February 28, 2018

Study information

• Verified date: April 2018
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 28, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Belgium	PZ Duffel	Duffel	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.