We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploring Effects of Electroconvulsive Therapy on the Human Brain in Depression - The Danish ECT/MRI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040388
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
Mental Health Centre Glostrup
Glostrup University Hospital, Copenhagen
Mental Health Centre Amager
Mental Health Centre Copenhagen
Information provided by (Responsible Party):
Poul Videbech, University of Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Depressive Disorder Depression Depressive Disorder, Major

Detailed 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 study consists of 60 inpatients, diagnosed with depression, admitted to one of the recruiting Mental Health Centres, and scheduled to ECT. The most modern MRI sequences examining brain structure and function are used at 3 time points: at baseline (just before ECT series), the second examination (just after ECT series) and the third (follow-up) examination (6 months after ECT series). Blood samples (measurements of Brain-Derived Neurotrophic Factor - BDNF, Vascular Endothelial Growth Factor - VEGF along with the marker of brain injury - S100B-protein) and the evaluation of clinical effect and side-effects to ECT are performed at the same time points.

The study has 4 main hypotheses. The first hypothesis assumes that the immediate and sustained response to ECT can be predicted by combining neuroimaging findings and blood-samples results. The second hypothesis is based on the assumption that ECT modulates the microstructure and connectivity in the fronto-limbic pathways (FLPs) and that this modulation correlates with the clinical effect. Thus, the altered microstructure of the FLPs in depression is normalised by an ECT series. Furthermore, the depression-associated increased resting state connectivity in FLPs is normalised by ECT. The third hypothesis is that ECT will induce changes in blood-brain barrier (BBB) permeability, which will correlate with the severity of memory problems. The last hypothesis assumes that ECT does not cause any brain tissue damage (including brain atrophy and white matter lesions - WMLs).

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Effects and Risk of Relapse Into Depression - The Danish ECT/MRI Project
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : June 11, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Volumetric changes in the hippocampus. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    This outcome will be measured by means of voxel-based morphometry (VBM).

  2. Changes in BDNF concentration in the blood. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
  3. Changes in regional cerebral blood flow (rCBF) in the frontal lobes. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    Pseudo-continuous arterial spin-labelling (PSCAL) will be used to measure this outcome.


Secondary Outcome Measures :
  1. The number of WMLs in the brain. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    FLAIR sequences of MRI will be used to measure this outcome.

  2. Changes in water diffusion in the brain. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    Diffusion-weighted imaging (DWI) will be used to measure this outcome.

  3. Changes in the level of fractional anisotropy (FA) in the brain. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    Diffusion tensor imaging (DTI) will be used to measure this outcome.

  4. Changes in the level of intrinsic connectivity pattern in fronto-limbic pathways in the brain. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    Resting state functional MRI will be used to measure this outcome.

  5. Changes in the glucose metabolism in the brain. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    Cerebral Metabolic Rate of Oxygen ( CMRO2) will be used to measure this outcome.

  6. Changes in blood-brain barrier (BBB) permeability. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]
    Dynamic Contrast Enhanced (DCE)T1-weighted imaging will be used to measure this outcome.

  7. Changes in S100B-protein concentration in the blood. [ Time Frame: at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series) ]

Biospecimen Retention:   Samples With DNA
Whole blood samples are kept in the biobank until the last enrolled patient has been examined. They will be then analysed for S100B-protein concentration and destroyed. Whole blood, serum and plasma samples are kept in the biobank until the last enrolled patient has been examined. They will then be analysed for concentrations of BDNF and VEGF and destroyed. Extra whole blood samples are stored in the psychiatric biobank for the future research (as part of another protocol - PSV-2001-04, I-Suite 00422 - ID nr 2001-54-798)

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of the inpatients admitted to one of the recruiting Mental Health Centres (MHC) in the Capital Region of Denmark (Mental Health Centre Glostrup or Amager or Copenhagen or others), diagnosed with either depression according to the 10th version of the International Classification of Diseases (ICD-10) or major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed (DSM-IV) and scheduled to ECT series.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040388


Locations
Layout table for location information
Denmark
Mental Health Centre Glostrup
Glostrup, The Capital Region, Denmark, 2600
Sponsors and Collaborators
University of Copenhagen
Mental Health Centre Glostrup
Glostrup University Hospital, Copenhagen
Mental Health Centre Amager
Mental Health Centre Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Poul Videbech, Professor Mental Health Centre Glostrup
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Poul Videbech, Professor, consultant in psychiatry, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03040388    
Other Study ID Numbers: DK-ECT-MR-1
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share Individual Patient Data.
Keywords provided by Poul Videbech, University of Copenhagen:
Electroconvulsive therapy
Depressive Disorder
Magnetic Resonance Imaging
Hippocampus
 Brain-Derived Neurotrophic Factor
Vascular Endothelial Growth Factor
Blood-Brain Barrier
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
 Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders