The Danish Neuropsychological Study on the Adverse Effects of ECT

  • STATUS
    Recruiting
  • End date
    Jun 17, 2023
  • participants needed
    290
  • sponsor
    University of Copenhagen
Updated on 17 February 2021

Summary

The main purpose of this study is to determine whether electroconvulsive therapy (ECT) causes any structural or functional brain changes and thus indicating its mechanism of action. The second aim is to find predictors of an immediate response, sustained remission, relapse and side-effects. Thirdly, this study aims to explore whether ECT causes any changes in blood-brain barriers permeability and whether these changes correlate to memory problems. The fourth objective is to examine whether ECT causes any brain tissue damage.

Description

ECT has been the most effective treatment of depression for decades. Despite of this, neither the mechanism of action or side-effects are fully elucidated. The reason why some patients relapse shortly after remission is still not completely understood. Thus, there is a need to find predictors of the favourable clinical effect, relapse and side-effects. ECT is considered by professionals to be a safe procedure. However, this view is based on rather old and small studies. Additionally, many patients do not consent to this treatment because they fear a permanent loss of memory or that they will contract a brain damage after the completed ECT series. Therefore, it is very important to examine whether ECT might have negative effects on the structure or function of the brain, using state of the art Magnetic Resonance Imaging (MRI) techniques on a greater study population.

The project is divided into Work Package 1 (WP1) and Work Package 2 (WP2).

WP1 is a prospective follow-up study with the aim of examining why cognitive side-effects of ECT occur and potentially find predictors for whom they may affect by investigating the ECT-associated cognitive disturbances, structural brain changes and clinical outcomes. WP1 comprises an ECT-group (45 patients) and a clinical control group (45 patients). The former consists of patients with depression receiving ECT, and the latter consists of matched patients with depression treated pharmacologically. The examinations will take place at three time-points; before, immediately after ECT or just before discharge, and 6 months after. WP1 is a naturalistic clinical project. This means that the number of ECT sessions given to the patients in the ECT-group is up to the referring physician.

WP2 is a cross sectional study with the aim of investigating the prevalence and severity of cognitive disturbances in an ECT-treated population of patients with depression, 6 months after the treatment. WP2 additionally aims to evaluate the validity of the objective and subjective cognitive disturbances by examining the associations between cognition measured by neuro-psychological tests and self-rating questionnaires, and how they transfer to a performance measure of daily cognitive function using a driving simulator. Approx. 200 patients will be included from the different participating Mental Health Centers. WP2 is a naturalistic clinical project. This means that the number of ECT sessions given to the patients is up to the referring physician.

The aim of DANSECT is to investigate the adverse side-effects of ECT in general, and on cognition in particular. Specifically, the research project aims to examine:

  1. Prevalence, extent and persistence of adverse cognitive effects following ECT (WP1+2)
  2. Prediction of adverse effects of ECT by combining sensitive neuropsychological tests, cutting edge structural neuroimaging (MRI) and other neurobiological measures (WP1)
  3. Associations between neuroimaging findings and clinical and cognitive effects (e.g. memory disturbances) (WP1)
  4. Short- and long-term mood symptoms and their association with objective and subjective cognitive effects of ECT (WP1+2)
  5. Molecular peripheral changes in neurotrophic factors, astrocyte marker, selected cytokines and microRNAs (miRNAs) of ECT (WP1)
    Hypotheses
  6. Elevated atrophy at baseline predicts increased risk of cognitive deficits at immediate follow-up and at 6 months
  7. Structural changes in the hippocampi from baseline to immediate follow-up will be a predictive biomarker for effects on explicit memory.
  8. Cell proliferation in the hippocampi as measured by spectroscopy will correlate with an effect on explicit memory at immediate follow-up.
  9. Cognitive performance at follow-up is predicted by severity of mood symptoms (MDI) and severity of objective (SCIP) and subjective (COBRA) cognitive function as measured at baseline
  10. The peripheral changes, i.e. Brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF), the astrocyte marker S100Beta, selected cytokines and miRNAs (related to depression, BDNF and VEGF) will correlate with improved subjective (COBRA) and objective (SCIP) cognitive function and clinical outcome (Hamilton + MDI) at follow-up
  11. Machine learning will reveal patterns and inference enabling the development of a predictive model of clinical and cognitive outcome after treatment with ECT, by combining neuropsychological tests, structural neuroimaging (MRI) and other neurobiological measures.

Details
Condition mood disorder, Affective Disorders, Mood Disorders, Mood Disorders (Pediatric), Endogenous depression, Depression, Depression (Adult and Geriatric), Depression (Treatment-Resistant), Depression (Major/Severe), Depression, Depression (Pediatric), Depression (Adolescent), Electroconvulsive Therapy, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Cognitive Impairment, Cognitive Dysfunction, Depressed, Cognitive Impairments, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, depressive disorder, neurocognitive disturbance, depressed mood, miserable, electroconvulsive therapy (ect), depressive disorders
Treatment Electroconvulsive therapy
Clinical Study IdentifierNCT04160286
SponsorUniversity of Copenhagen
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

age 18-95 years
admitted at the MHC Glostrup, MHC Amager or MHC Copenhagen (or other Mental Health Centres in the Capital Region)
fulfilling the criteria for depression according to ICD-10 and major depression according to DSM-IV and where ECT is planned
must be able to give informed consent to participate in the study

Exclusion Criteria

Schizophrenia or any other psychotic disorder except for psychotic depression
Dependency syndrome according to ICD-10
Severe somatic or neurological condition (e.g. stroke) confounding results
Head trauma resulting in unconsciousness for more than 5 minutes
Severe psychotic symptoms or suicide impulses making transportation hazardous
Contraindications against MRI or Gadovist infusion
Pregnancy
Maintenance ECT or ECT received during the last 6 months
Any form of compulsory treatment
Subjects who do not consent to be informed of incidental findings that could have healthcare implications will not be scanned and can thus not be included
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