Depressive DisorderDANSECTNCT04160286
The Danish Neuropsychological Study of the Adverse Effects of ECT
An observational study of Depressive Disorder and Depression, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Depressive Disorder, Depression, Cognitive Dysfunction
- What is being tested?
- Electroconvulsive therapy
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2020to 25 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mental Health Services of the Capital Region of Denmark
Copenhagen, 2100
About this study
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.
Read the 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. 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.
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:
- Prevalence, extent and persistence of adverse cognitive effects following ECT.
- Associations between neuroimaging findings and cognitive changes following ECT.
- Predictors of adverse cognitive effects of ECT.
Hypotheses:
- 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.
- Autobiographical memory deterioration is expected to correlate with volumetric changes of the hippocampi.
- 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.
- Baseline atrophy, age, years of education and cognitive reserve will predict the cognitive side-effects following ECT.
- 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:
- Clinical, biochemical and neurobiological predictors of response to ECT
- Clinical, biochemical and neurobiological predictors of relapse of depression after ECT
- Biochemical and neurobiological mechanisms of response to ECT
Hypotheses:
- Smaller baseline hippocampal volume is associated with a larger post-pre reduction of depressive symptoms
- Thinner cortical thickness predicts better clinical improvement
- The cortisol trajectory before ECT is associated with clinical outcome
- Elevated peripheral baseline VEGF is associated with a larger post-pre reduction of depressive symptoms
- Baseline microRNA levels are associated with clinical outcome
- A higher baseline structural connectivity predicts better clinical improvement
- 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
- Being tested
- Electroconvulsive therapy
- Keywords
- Hippocampus, Depression, Electroconvulsive therapy, Brain-Derived Neurotrophic Factor, Magnetic Resonance Imaging, Autobiographical memory, Cognitive side-effects
- Medical subject headings
- Depressive Disorder, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| ECT | Group of patients receiving ECT during their hospitalization. Receives: Other: Electroconvulsive therapy | |
| Non-ECT | Group of patients not receiving ECT during their hospitalization. | |
| Healthy controls | Group of healthy participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at follow-up (6 (+/-2) months after the ECT series
Secondary outcomes (15)
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale 6-item. Scoring: Minimum: 0. Maximum: 22. A higher score means more symptom severity.
Measured: 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
Screening tool to measure cognitive performance across several cognitive domains. Scoring: Minimum 0. Maximum: Unlimited. A higher score means a better cognitive performance.
Measured: 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
Measures visuospatial, constructional, executive and anterograde memory abilities. Scoring: Minimum: 0. Maximum: 36. A higher score means a better cognitive performance.
Measured: 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
Measures psychomotor speed. Scoring: Minimum:0. Maximum: Unlimited. A higher score means a worse cognitive performance.
Measured: 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
Measures complex psychomotor speed / executive function. Scoring: Minimum:0. Maximum: Unlimited. A higher score means a worse cognitive performance.
Measured: 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)
Digit span (WAIS-IV)
Measures attention span (forwards) and working memory (backwards). Scoring: Minimum: 0. Maximum: 16.
Measured: 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)
Five Point Test
Measures spatial fluency / problem solving. Scoring: Minimum: 0. Maximum: Unlimited. A higher score means a better cognitive performance.
Measured: 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)
Color-Word Interference Test (D-KEFS)
Measures psychomotor speed, meantal flexibility and set-shifting. Scoring: Minimum: 0. Maximum: Unlimited. A higher score means a worse cognitive performance.
Measured: 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)
Symbol Digit Modalities Test
Measures psychomotor speed. Scoring: Minimum: 0. Maximum: Unlimited. A higher score means a worse cognitive performance.
Measured: 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)
Vividness of Visual Imagery Questionnaire - Danish version
Measures subjective experience of the vividness of ones mental visual imagery. Scoring: Minimum: 16. Maximum: 80. A higher score means more vividly experienced mental imagery.
Measured: 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)
Vocabulary (WAIS-IV)
Measures vocabulary and serves as an estimate of premorbid intellectual ability. Scoring: Minimum: 0. Maximum: 57. A higher score means a better vocabulary.
Measured: at one time point: at 5 (+/- 2) days after completion of the ECT series
Cognitive complaints in bipolar disorder rating assessment
Self-report of experienced cognitive difficulties. Scoring: Minimum: 0. Maximum: 48. A higher score means more symptom severity.
Measured: 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)
Squire Subjective Memory Questionnaire
Self-report of experienced memory difficulties. Scoring: Minimum: -72. Maximum: +72. A higher score means a better cognitive function.
Measured: 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)
Paired Associates Learning (CANTAB)
Visuospatial pattern localization. Scoring: Minimum 0. Maximum: Unlimited. A higher score (errors) means a worse cognitive performance.
Measured: 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)
WHO-5
Self-report of well-being in the last 14 days. Scoring: Minimum: 0. Maximum: 25. A higher score means a better experience of well-being.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start12 Nov 2020
- Primary completion1 Feb 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Poul Videbech, University of Copenhagen
- Investigators
- Poul Videbech, Professor, Principal investigator, University of Copenhagen & Mental Health Centre Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160286
- Sponsor's protocol ID
- DANSECT
- Acronym
- DANSECT
- Status last verified
- Feb 2023
- First submitted
- 6 Nov 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share Individual Patient Data.
Publications
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.
PubMed 24381234Andrade 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.
PubMed 24800688Ahdidan 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.
PubMed 21219263Arts 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.
PubMed 16957538Awata 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.
PubMed 11929569Bergsholm 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.
PubMed 2618780Beyer 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.
PubMed 16513039Bolwig 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.
PubMed 404164Bolwig TG. How does electroconvulsive therapy work? Theories on its mechanism. Can J Psychiatry. 2011 Jan;56(1):13-8. doi: 10.1177/070674371105600104.
PubMed 21324238Bolwig TG. Neuroimaging and electroconvulsive therapy: a review. J ECT. 2014 Jun;30(2):138-42. doi: 10.1097/YCT.0000000000000140.
PubMed 24800687Bronge 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.
PubMed 18445741Brunoni 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.
PubMed 24628093Campbell 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.
PubMed 11449035Coffey 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.
PubMed 1747016Dukart 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.
PubMed 24379394
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Neuropsychological Study of the Adverse Effects of ECT
- ClinicalTrials.gov ID
- NCT04160286
- Acronym / sponsor ID
- DANSECT / DANSECT
- Keywords
- Hippocampus, Depression, Electroconvulsive therapy, Brain-Derived Neurotrophic Factor, Magnetic Resonance Imaging, Autobiographical memory, Cognitive side-effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
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:
- Prevalence, extent and persistence of adverse cognitive effects following ECT.
- Associations between neuroimaging findings and cognitive changes following ECT.
- Predictors of adverse cognitive effects of ECT.
Hypotheses:
- 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.
- Autobiographical memory deterioration is expected to correlate with volumetric changes of the hippocampi.
- 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.
- Baseline atrophy, age, years of education and cognitive reserve will predict the cognitive side-effects following ECT.
- 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:
- Clinical, biochemical and neurobiological predictors of response to ECT
- Clinical, biochemical and neurobiological predictors of relapse of depression after ECT
- Biochemical and neurobiological mechanisms of response to ECT
Hypotheses:
- Smaller baseline hippocampal volume is associated with a larger post-pre reduction of depressive symptoms
- Thinner cortical thickness predicts better clinical improvement
- The cortisol trajectory before ECT is associated with clinical outcome
- Elevated peripheral baseline VEGF is associated with a larger post-pre reduction of depressive symptoms
- Baseline microRNA levels are associated with clinical outcome
- A higher baseline structural connectivity predicts better clinical improvement
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECT | – | Other: Electroconvulsive therapyGroup of patients receiving ECT during their hospitalization. |
| Non-ECT | – | –Group of patients not receiving ECT during their hospitalization. |
| Healthy controls | – | –Group of healthy participants. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapyElectroconvulsive 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) | Other | ECT |
Primary outcome
Columbia Autobiographical Memory Interview - Short Form
Time frame: at baseline (before ECT series)
Measures consistency in autobiographical memories over time. Scoring: Minimum: 0. Maximum: 60. A higher score means a better cognitive performance.
Columbia Autobiographical Memory Interview - Short Form
Time frame: at 5 (+/- 2) days after completion of the ECT series
Measures consistency in autobiographical memories over time. Scoring: Minimum: 0. Maximum: 60. A higher score means a better cognitive performance.
Columbia Autobiographical Memory Interview - Short Form
Time frame: at follow-up (6 (+/-2) months after the ECT series
Measures consistency in autobiographical memories over time. Scoring: Minimum: 0. Maximum: 60. A higher score means a better cognitive performance.
15 secondary outcomes
Hamilton Depression Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Digit span (WAIS-IV)
Time frame: 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)
Five Point Test
Time frame: 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)
Color-Word Interference Test (D-KEFS)
Time frame: 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)
Symbol Digit Modalities Test
Time frame: 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)
Vividness of Visual Imagery Questionnaire - Danish version
Time frame: 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)
Vocabulary (WAIS-IV)
Time frame: at one time point: at 5 (+/- 2) days after completion of the ECT series
Cognitive complaints in bipolar disorder rating assessment
Time frame: 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)
Squire Subjective Memory Questionnaire
Time frame: 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)
Paired Associates Learning (CANTAB)
Time frame: 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)
WHO-5
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 24381234Abbott 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.
- Background: PubMed 24800688Andrade 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.
- Background: PubMed 21219263Ahdidan 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.
- Background: PubMed 16957538Arts 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.
- Background: PubMed 11929569Awata 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.
- Background: PubMed 2618780Bergsholm 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.
- Background: PubMed 16513039Beyer 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.
- Background: PubMed 404164Bolwig 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.
- Background: PubMed 21324238Bolwig TG. How does electroconvulsive therapy work? Theories on its mechanism. Can J Psychiatry. 2011 Jan;56(1):13-8. doi: 10.1177/070674371105600104.
- Background: PubMed 24800687Bolwig TG. Neuroimaging and electroconvulsive therapy: a review. J ECT. 2014 Jun;30(2):138-42. doi: 10.1097/YCT.0000000000000140.
- Background: PubMed 18445741Bronge 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.
- Background: PubMed 24628093Brunoni 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.
- Danish Health Authority: Reference Programme for Treating Unipolar Depression in adults. 2007.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share Individual Patient Data.
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poul Videbech, Professor principal investigator
University of Copenhagen & Mental Health Centre Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Depression, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Autobiographical Memory Interview - Short Form (time frame: at baseline (before ECT series)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160286, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.