Prediction of the Cognitive Effects of Electroconvulsive Therapy Via Machine Learning and Neuroimaging

NCT03490149 | Unknown

• 1 other identifier: CoEffECT - Study
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to use machine learning to predict the occurrence of episodic and autobiographical memory deficits as well as treatment response following a course of electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive effects after a course of ECT will be investigated. Therefore, structural, resting-state and diffusion tensor images will be collected within one week before the first and after the last ECT treatment from severely depressed patients. Standard measures of cognitive function and specifically episodic as well as autobiographical memory will also be collected longitudinally and used for prediction. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression, 60 medication-only controls and 60 healthy controls.

Conditions

ECT; Depression; Cognitive Impairment; Memory Impairment

Keywords

ECT; Electroconvulsive Therapy; Depression; Memory; Memory Impairment

Outcome Measures

Primary Outcomes (4)

• Change in auditory verbal learning performance

  Auditory Verbal Learning Test (AVLT)

  Within one week before first and one week after last ECT

• Change in autobiographical memory performance

  Autobiographical Memory Interview (AMI-SF)

  Within one week before first and one week after last ECT

• Change in subjective memory impairment

  Qualitative Interview

  Within one week before first and one week after last ECT

• Occurence of retrograde amnesia

  Within the first week after last ECT

Secondary Outcomes (2)

• Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS 28).

  One week before first and one week after last ECT

• Change in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)

  One week before first and one week after last ECT

Study Arms (3)

ECT

Device: Electroconvulsive Therapy

Medication - Treatment as usual

Drug: Medication - Treatment as usual

Healthy controls

Interventions

Electroconvulsive Therapy DEVICE

Series of electroconvulsive therapy for major depressive disorder

ECT

Medication - Treatment as usual DRUG

Medication only sample - Treatment as usual

Medication - Treatment as usual

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients at the psychiatric hospital of the University Hospital Bonn. The patients diagnosis of major depressive disorder will be verified via the structured clinical interview for DSM-5. ECT protocol in line with international standards administered by a staff psychiatrist. Additionally, a medication-only and a healthy control sample are included in the study.

You may qualify if:

• The duration of the current depressive episode is at least four weeks
• The duration of the current depressive episode is less than five years
• Inpatients of the psychiatric clinic of the University Hospital Bonn and eligible for ECT because of major depressive disorder or major depressive episode in bipolar disorder (according to DSM-5 criteria)
• Score on HDRS 28 ≥ 20
• Ability to understand the purpose of and procedures required for the study and willingness to consent to participation
• Meeting of standard medical prerequisites for ECT (judged by staff psychiatrist)
• Ability to speak and understand the german language

You may not qualify if:

• No lifetime occurence of a personality disorder
• Current (or within the last year) posttraumatic stress disorder
• Schizophrenia or any other psychotic disorder except for psychotic depression
• Severe somatic or neurological condition (e.g. stroke)
• Head trauma resulting in unconsciousness for more than 5 minutes
• Pregnancy
• Maintenance ECT or ECT received during the last 6 month
• Subjects who do not consent to be informed of incidental findings that could have healthcare implications
• Drug or alcohol dependence (\<6 month before ECT)
• Is currently enrolled in a study with an investigational study drug
• Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements

Sponsors & Collaborators

• University Hospital, Bonn: lead
• Maximilian Kiebs, M.Sc. - University Hospital Bonn (Department of Medical Psychology): collaborator

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, North Rhine-Westphalia, 53105, Germany

RECRUITING

Related Publications (19)

• Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.

  PMID: 23993280 BACKGROUND

• Sinyor M, Schaffer A, Levitt A. The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review. Can J Psychiatry. 2010 Mar;55(3):126-35. doi: 10.1177/070674371005500303.

  PMID: 20370962 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

• Haq AU, Sitzmann AF, Goldman ML, Maixner DF, Mickey BJ. Response of depression to electroconvulsive therapy: a meta-analysis of clinical predictors. J Clin Psychiatry. 2015 Oct;76(10):1374-84. doi: 10.4088/JCP.14r09528.

  PMID: 26528644 BACKGROUND

• Sackeim HA. Modern Electroconvulsive Therapy: Vastly Improved yet Greatly Underused. JAMA Psychiatry. 2017 Aug 1;74(8):779-780. doi: 10.1001/jamapsychiatry.2017.1670. No abstract available.

  PMID: 28658461 BACKGROUND

• Slade EP, Jahn DR, Regenold WT, Case BG. Association of Electroconvulsive Therapy With Psychiatric Readmissions in US Hospitals. JAMA Psychiatry. 2017 Aug 1;74(8):798-804. doi: 10.1001/jamapsychiatry.2017.1378.

  PMID: 28658489 BACKGROUND

• Aoki Y, Yamaguchi S, Ando S, Sasaki N, Bernick PJ, Akiyama T. The experience of electroconvulsive therapy and its impact on associated stigma: A meta-analysis. Int J Soc Psychiatry. 2016 Dec;62(8):708-718. doi: 10.1177/0020764016675379. Epub 2016 Oct 26.

  PMID: 27798050 BACKGROUND

• Bailine S. Reimbursement and documentation issues in an ambulatory ECT program. J ECT. 1998 Dec;14(4):255-8.

  PMID: 9871847 BACKGROUND

• Case BG, Bertollo DN, Laska EM, Price LH, Siegel CE, Olfson M, Marcus SC. Declining use of electroconvulsive therapy in United States general hospitals. Biol Psychiatry. 2013 Jan 15;73(2):119-26. doi: 10.1016/j.biopsych.2012.09.005. Epub 2012 Oct 8.

  PMID: 23059049 BACKGROUND

• Wilhelmy S, Rolfes V, Grozinger M, Chikere Y, Schottle S, Gross D. Knowledge and attitudes on electroconvulsive therapy in Germany: A web based survey. Psychiatry Res. 2018 Apr;262:407-412. doi: 10.1016/j.psychres.2017.09.015. Epub 2017 Sep 11.

  PMID: 28923432 BACKGROUND

• Wilkinson D, Daoud J. The stigma and the enigma of ECT. Int J Geriatr Psychiatry. 1998 Dec;13(12):833-5. doi: 10.1002/(sici)1099-1166(1998120)13:123.0.co;2-r. No abstract available.

  PMID: 9884906 BACKGROUND

• Dwork AJ, Arango V, Underwood M, Ilievski B, Rosoklija G, Sackeim HA, Lisanby SH. Absence of histological lesions in primate models of ECT and magnetic seizure therapy. Am J Psychiatry. 2004 Mar;161(3):576-8. doi: 10.1176/appi.ajp.161.3.576.

  PMID: 14992989 BACKGROUND

• Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 2010 Sep 15;68(6):568-77. doi: 10.1016/j.biopsych.2010.06.009. Epub 2010 Jul 31.

  PMID: 20673880 BACKGROUND

• Payne NA, Prudic J. Electroconvulsive therapy: Part I. A perspective on the evolution and current practice of ECT. J Psychiatr Pract. 2009 Sep;15(5):346-68. doi: 10.1097/01.pra.0000361277.65468.ef.

  PMID: 19820553 BACKGROUND

• Prudic J, Peyser S, Sackeim HA. Subjective memory complaints: a review of patient self-assessment of memory after electroconvulsive therapy. J ECT. 2000 Jun;16(2):121-32. doi: 10.1097/00124509-200006000-00004.

  PMID: 10868322 BACKGROUND

• Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.

  PMID: 10839336 BACKGROUND

• Sackeim HA. Autobiographical memory and electroconvulsive therapy: do not throw out the baby. J ECT. 2014 Sep;30(3):177-86. doi: 10.1097/YCT.0000000000000117.

  PMID: 24755727 BACKGROUND

• Sackeim HA. Memory and ECT: from polarization to reconciliation. J ECT. 2000 Jun;16(2):87-96. doi: 10.1097/00124509-200006000-00001. No abstract available.

  PMID: 10868319 BACKGROUND

• Redlich R, Opel N, Grotegerd D, Dohm K, Zaremba D, Burger C, Munker S, Muhlmann L, Wahl P, Heindel W, Arolt V, Alferink J, Zwanzger P, Zavorotnyy M, Kugel H, Dannlowski U. Prediction of Individual Response to Electroconvulsive Therapy via Machine Learning on Structural Magnetic Resonance Imaging Data. JAMA Psychiatry. 2016 Jun 1;73(6):557-64. doi: 10.1001/jamapsychiatry.2016.0316.

  PMID: 27145449 BACKGROUND

MeSH Terms

Conditions

Depression; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rene Hurlemann, Prof.

  University Hospital, Bonn

  STUDY DIRECTOR

Central Study Contacts

Maximilian Kiebs, M.Sc.

CONTACT

0049228287; m.kiebs@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 6, 2018
• Study Start: January 2, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)