Clinical trial NCT02562846: PRediction Of Treatment Response to ECT in Depression and Cognitive Side effecTs
Official title: Prediction of ECT Treatment Response in Depression and Early Detection of ECT-related Memory Problems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: electroconvulsive therapy
response prediction
cognitive side effects
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Duffel
country: Belgium
facility: PZ Duffel
state: Antwerp
Study officials:
affiliation: Duffel Psychiatric Hospital
name: Bernard Sabbe, MD, prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Hebbrecht 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.
citation: Baeten 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.
citation: Belge 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.
citation: van 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.
citation: van 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.