The Danish Neuropsychological Study of the Adverse Effects of ECT
NCT ID: NCT04160286
Last Updated: 2025-04-16
Study Results
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Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2020-11-12
2024-11-25
Brief Summary
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Detailed Description
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DANSECT is a prospective, observational 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. Second, DANSECT examines the mechanisms of effect of ECT.
DANSECT comprises an ECT-group (30 patients) and a clinical control group (30 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. DANSECT 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.
The aim of DANSECT is to investigate the cognitive side-effects of ECT. Specifically, the research project aims to examine:
1. Prevalence, extent and persistence of adverse cognitive effects following ECT.
2. Associations between neuroimaging findings and cognitive changes following ECT.
3. Predictors of adverse cognitive effects of ECT.
Hypotheses:
1. Consistency in autobiographical memories will be reduced over time in both study groups. However, the reduction will be significantly larger for the ECT patients after ECT compared to the control group. The group difference is expected to be present at both short-term and long-term.
2. Autobiographical memory deterioration is expected to correlate with volumetric changes of the hippocampi.
3. Processing speed, anterograde memory and executive functions will be temporarily deteriorated after ECT. The cognitive changes will correlate with volumetric brain changes and changes in structural connectivity.
4. Baseline atrophy, age, years of education and cognitive reserve will predict the cognitive side-effects following ECT.
5. 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 and functional neuroimaging (MRI) and other neurobiological measures.
In addition, the aim of DANSECT is to investigate the mechanisms of effect of ECT. The secondary aims of the project are thus to examine:
1. Clinical, biochemical and neurobiological predictors of response to ECT
2. Clinical, biochemical and neurobiological predictors of relapse of depression after ECT
3. Biochemical and neurobiological mechanisms of response to ECT
Hypotheses:
1. Smaller baseline hippocampal volume is associated with a larger post-pre reduction of depressive symptoms
2. Thinner cortical thickness predicts better clinical improvement
3. The cortisol trajectory before ECT is associated with clinical outcome
4. Elevated peripheral baseline VEGF is associated with a larger post-pre reduction of depressive symptoms
5. Baseline microRNA levels are associated with clinical outcome
6. A higher baseline structural connectivity predicts better clinical improvement
7. A larger post-ECT increase in hippocampal volume, cortical thickness, BDNF and VEGF predicts a lower risk of relapse within six months after an ECT series
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ECT
Group of patients receiving ECT during their hospitalization.
Electroconvulsive therapy
Electroconvulsive therapy is a procedure, done under general anesthesia, in which small electric currents are passed through the brain, intentionally triggering a brief seizure.
Repeated as deemed needed by the patients' doctor. Typically prescribed 10 times (3 times pr week)
Non-ECT
Group of patients not receiving ECT during their hospitalization.
No interventions assigned to this group
Healthy controls
Group of healthy participants.
No interventions assigned to this group
Interventions
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Electroconvulsive therapy
Electroconvulsive therapy is a procedure, done under general anesthesia, in which small electric currents are passed through the brain, intentionally triggering a brief seizure.
Repeated as deemed needed by the patients' doctor. Typically prescribed 10 times (3 times pr week)
Eligibility Criteria
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Inclusion Criteria
* 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 where ECT is planned.
* must be able to give informed consent to participate in the study
Exclusion Criteria
* 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
* 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
18 Years
95 Years
ALL
No
Sponsors
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Mental Health Centre Glostrup
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Poul Videbech
Professor, consultant in psychiatry
Principal Investigators
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Poul Videbech, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen & Mental Health Centre Glostrup
Locations
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Mental Health Services of the Capital Region of Denmark
Copenhagen, , Denmark
Countries
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References
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Abbott CC, Gallegos P, Rediske N, Lemke NT, Quinn DK. A review of longitudinal electroconvulsive therapy: neuroimaging investigations. J Geriatr Psychiatry Neurol. 2014 Mar;27(1):33-46. doi: 10.1177/0891988713516542. Epub 2013 Dec 30.
Andrade C, Bolwig TG. Electroconvulsive therapy, hypertensive surge, blood-brain barrier breach, and amnesia: exploring the evidence for a connection. J ECT. 2014 Jun;30(2):160-4. doi: 10.1097/YCT.0000000000000133.
Ahdidan J, Hviid LB, Chakravarty MM, Ravnkilde B, Rosenberg R, Rodell A, Stodkilde-Jorgensen H, Videbech P. Longitudinal MR study of brain structure and hippocampus volume in major depressive disorder. Acta Psychiatr Scand. 2011 Mar;123(3):211-9. doi: 10.1111/j.1600-0447.2010.01644.x. Epub 2011 Jan 11.
Arts B, Peters M, Ponds R, Honig A, Menheere P, van Os J. S100 and impact of ECT on depression and cognition. J ECT. 2006 Sep;22(3):206-12. doi: 10.1097/01.yct.0000235925.37494.2c.
Awata S, Konno M, Kawashima R, Suzuki K, Sato T, Matsuoka H, Fukuda H, Sato M. Changes in regional cerebral blood flow abnormalities in late-life depression following response to electroconvulsive therapy. Psychiatry Clin Neurosci. 2002 Feb;56(1):31-40. doi: 10.1046/j.1440-1819.2002.00927.x.
Bergsholm P, Larsen JL, Rosendahl K, Holsten F. Electroconvulsive therapy and cerebral computed tomography. A prospective study. Acta Psychiatr Scand. 1989 Dec;80(6):566-72. doi: 10.1111/j.1600-0447.1989.tb03027.x.
Beyer JL. Volumetric brain imaging studies in the elderly with mood disorders. Curr Psychiatry Rep. 2006 Feb;8(1):18-24. doi: 10.1007/s11920-006-0077-0.
Bolwig TG, Hertz MM, Paulson OB, Spotoft H, Rafaelsen OJ. The permeability of the blood-brain barrier during electrically induced seizures in man. Eur J Clin Invest. 1977 Apr;7(2):87-93. doi: 10.1111/j.1365-2362.1977.tb01578.x.
Bolwig TG. How does electroconvulsive therapy work? Theories on its mechanism. Can J Psychiatry. 2011 Jan;56(1):13-8. doi: 10.1177/070674371105600104.
Bolwig TG. Neuroimaging and electroconvulsive therapy: a review. J ECT. 2014 Jun;30(2):138-42. doi: 10.1097/YCT.0000000000000140.
Bronge L, Wahlund LO. White matter changes in dementia: does radiology matter? Br J Radiol. 2007 Dec;80 Spec No 2:S115-20. doi: 10.1259/bjr/35265137.
Brunoni AR, Baeken C, Machado-Vieira R, Gattaz WF, Vanderhasselt MA. BDNF blood levels after electroconvulsive therapy in patients with mood disorders: a systematic review and meta-analysis. World J Biol Psychiatry. 2014 Jul;15(5):411-8. doi: 10.3109/15622975.2014.892633. Epub 2014 Mar 16.
Campbell JJ 3rd, Coffey CE. Neuropsychiatric significance of subcortical hyperintensity. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):261-88. doi: 10.1176/jnp.13.2.261. No abstract available.
Coffey CE, Weiner RD, Djang WT, Figiel GS, Soady SA, Patterson LJ, Holt PD, Spritzer CE, Wilkinson WE. Brain anatomic effects of electroconvulsive therapy. A prospective magnetic resonance imaging study. Arch Gen Psychiatry. 1991 Nov;48(11):1013-21. doi: 10.1001/archpsyc.1991.01810350053008.
Dukart J, Regen F, Kherif F, Colla M, Bajbouj M, Heuser I, Frackowiak RS, Draganski B. Electroconvulsive therapy-induced brain plasticity determines therapeutic outcome in mood disorders. Proc Natl Acad Sci U S A. 2014 Jan 21;111(3):1156-61. doi: 10.1073/pnas.1321399111. Epub 2013 Dec 30.
Fitzgerald PB, Laird AR, Maller J, Daskalakis ZJ. A meta-analytic study of changes in brain activation in depression. Hum Brain Mapp. 2008 Jun;29(6):683-95. doi: 10.1002/hbm.20426.
UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003 Mar 8;361(9360):799-808. doi: 10.1016/S0140-6736(03)12705-5.
Herrmann LL, Le Masurier M, Ebmeier KP. White matter hyperintensities in late life depression: a systematic review. J Neurol Neurosurg Psychiatry. 2008 Jun;79(6):619-24. doi: 10.1136/jnnp.2007.124651. Epub 2007 Aug 23.
Related Links
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Danish Health Authority: Reference Programme for Treating Unipolar Depression in adults. 2007.
Other Identifiers
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DANSECT
Identifier Type: -
Identifier Source: org_study_id
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