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

NCT03040388 | Completed

• 1 other identifier: DK-ECT-MR-1
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major

Keywords

Electroconvulsive therapy; Depressive Disorder; Magnetic Resonance Imaging; Hippocampus; Brain-Derived Neurotrophic Factor; Vascular Endothelial Growth Factor; Blood-Brain Barrier

Outcome Measures

Primary Outcomes (3)

• Volumetric changes in the hippocampus.

  This outcome will be measured by means of voxel-based morphometry (VBM).

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

• Changes in BDNF concentration in the blood.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

• Changes in regional cerebral blood flow (rCBF) in the frontal lobes.

  Pseudo-continuous arterial spin-labelling (PSCAL) will be used to measure this outcome.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

Secondary Outcomes (7)

• The number of WMLs in the brain.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

• Changes in water diffusion in the brain.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

• Changes in the level of fractional anisotropy (FA) in the brain.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

• Changes in the level of intrinsic connectivity pattern in fronto-limbic pathways in the brain.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

• Changes in the glucose metabolism in the brain.

  at 3 time points: at baseline (before ECT series), after an ECT series (+3 day), at follow-up (6 months after the ECT series)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Glostrup University Hospital, Copenhagen: collaborator
• Amager Hospital: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (1)

Mental Health Centre Glostrup

Glostrup Municipality, The Capital Region, 2600, Denmark

Location

Related Publications (57)

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Related Links

• Sundhedsstyrelsen: Referenceprogram for Unipolar Depression hos voksne. 2007.
• Ottosson J-O, Fink M. Ethics in electroconvulsive therapy. New York: Brunner-Reoutledge, 2004.

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)

MeSH Terms

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Poul Videbech, Professor

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant in psychiatry

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 2, 2017
• Study Start: August 9, 2017
• Primary Completion: October 30, 2019
• Study Completion: June 11, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)