The Danish Neuropsychological Study of the Adverse Effects of ECT

NCT04160286 | Completed

• 1 other identifier: DANSECT
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to investigate the adverse cognitive side-effects of electroconvulsive therapy (ECT). The second aim is to investigate the mechanisms of effect of ECT.

Conditions

Depressive Disorder; Depression; Cognitive Dysfunction; Electroconvulsive Therapy

Keywords

Hippocampus; Depression; Electroconvulsive therapy; Brain-Derived Neurotrophic Factor; Magnetic Resonance Imaging; Autobiographical memory; Cognitive side-effects

Outcome Measures

Primary Outcomes (3)

• Columbia Autobiographical Memory Interview - Short Form

  Measures consistency in autobiographical memories over time. Scoring: Minimum: 0. Maximum: 60. A higher score means a better cognitive performance.

  at baseline (before ECT series)

• Columbia Autobiographical Memory Interview - Short Form

  Measures consistency in autobiographical memories over time. Scoring: Minimum: 0. Maximum: 60. A higher score means a better cognitive performance.

  at 5 (+/- 2) days after completion of the ECT series

• Columbia Autobiographical Memory Interview - Short Form

  Measures consistency in autobiographical memories over time. Scoring: Minimum: 0. Maximum: 60. A higher score means a better cognitive performance.

  at follow-up (6 (+/-2) months after the ECT series

Secondary Outcomes (15)

• Hamilton Depression Rating Scale

  at 3 time points: at baseline (before ECT series), at 5 (+/- 2) days after completion of the ECT series, at follow-up (6 (+/-2) months after the ECT series)

• The Screen for Cognitive Impairment for Psychiatry

  at 3 time points: at baseline (before ECT series), at 5 (+/- 2) days after completion of the ECT series, at follow-up (6 (+/-2) months after the ECT series)

• Reys complex figure task

  at 3 time points: at baseline (before ECT series), at 5 (+/- 2) days after completion of the ECT series, at follow-up (6 (+/-2) months after the ECT series)

• Trail Making Test A

  at 3 time points: at baseline (before ECT series), at 5 (+/- 2) days after completion of the ECT series, at follow-up (6 (+/-2) months after the ECT series)

• Trail Making Test B

  at 3 time points: at baseline (before ECT series), at 5 (+/- 2) days after completion of the ECT series, at follow-up (6 (+/-2) months after the ECT series)

Study Arms (3)

ECT

Group of patients receiving ECT during their hospitalization.

Other: Electroconvulsive therapy

Non-ECT

Group of patients not receiving ECT during their hospitalization.

Healthy controls

Group of healthy participants.

Interventions

Electroconvulsive therapy OTHER

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)

ECT

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 two groups of inpatients admitted to one of the recruiting Mental Health Centres (MHC) in the Capital Region of Denmark, diagnosed with depression according to the 10th version of the International Classification of Diseases (ICD-10) and scheduled to ECT series. Patients in the other group does not received ECT and is thus a control group.

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 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
• 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

Study Sites (1)

Mental Health Services of the Capital Region of Denmark

Copenhagen, 2100, Denmark

Location

Related Publications (19)

• 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.

  PMID: 24381234 BACKGROUND

• 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.

  PMID: 24800688 BACKGROUND

• 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.

  PMID: 21219263 BACKGROUND

• 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.

  PMID: 16957538 BACKGROUND

• 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.

  PMID: 11929569 BACKGROUND

• 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.

  PMID: 2618780 BACKGROUND

• 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.

  PMID: 16513039 BACKGROUND

• 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.

  PMID: 404164 BACKGROUND

• Bolwig TG. How does electroconvulsive therapy work? Theories on its mechanism. Can J Psychiatry. 2011 Jan;56(1):13-8. doi: 10.1177/070674371105600104.

  PMID: 21324238 BACKGROUND

• Bolwig TG. Neuroimaging and electroconvulsive therapy: a review. J ECT. 2014 Jun;30(2):138-42. doi: 10.1097/YCT.0000000000000140.

  PMID: 24800687 BACKGROUND

• 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.

  PMID: 18445741 BACKGROUND

• 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.

  PMID: 24628093 BACKGROUND

• 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.

  PMID: 11449035 BACKGROUND

• 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.

  PMID: 1747016 BACKGROUND

• 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.

  PMID: 24379394 BACKGROUND

• 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.

  PMID: 17598168 BACKGROUND

• 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.

  PMID: 12642045 BACKGROUND

• 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.

  PMID: 17717021 BACKGROUND

• Mathiassen AB, Lundsgaard CC, Gbyl K, Miskowiak K, Fagerlund B, Larsson HBW, Lindberg U, Videbech P. Brain reserve in memory regions is associated with the preservation of autobiographical memories after electroconvulsive therapy. Front Psychiatry. 2025 Nov 10;16:1699102. doi: 10.3389/fpsyt.2025.1699102. eCollection 2025.

  PMID: 41293195 DERIVED

Related Links

• Danish Health Authority: Reference Programme for Treating Unipolar Depression in adults. 2007.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, urine samples and hair samples are kept in the biobank until the last enrolled patient has been examined.

MeSH Terms

Conditions

Depressive Disorder; Depression; Cognitive Dysfunction

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Poul Videbech, Professor

  University of Copenhagen & Mental Health Centre Glostrup

  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: November 6, 2019
• First Posted: November 12, 2019
• Study Start: November 12, 2020
• Primary Completion: February 1, 2024
• Study Completion: November 25, 2024
• Last Updated: April 16, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)