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

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ClinicalTrials.gov Identifier: NCT03490149
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Maximilian Kiebs, M.Sc. - University Hospital Bonn (Department of Medical Psychology)
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

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.


Condition or disease Intervention/treatment
ECT Depression Cognitive Impairment Memory Impairment Device: Electroconvulsive Therapy Drug: Medication - Treatment as usual

Detailed Description:

Due to the immense disease burden of major depression and unsatisfactory response to standard pharmacological and psychological treatments, the need for treatment alternatives is evident. Electroconvulsive therapy (ECT) remains to be the most efficacious treatment known for treatment-resistant depression. However, although many studies show response rates above 70%, ECT can be considered vastly underused. Reasons contributing to this phenomenon may include stigma, regulatory restrictions, limited medical training, safety and side-effect concerns, or reluctance among professionals to recommend ECT. Most of these reasons have already been refuted or put into perspective by psychological and neuroscientific studies (e.g. ECT causes brain lesions) and most cognitive deficits related to the ECT course seem to fade after several weeks of discontinuation.

Still, in terms of the tolerability, memory disturbances remain the most problematic effect of ECT. Besides subjective reports from patients after a course of ECT, experimental studies have also found evidence of episodic and autobiographical memory impiarment attributable to ECT. The origins of these effects are still largely unknown and remain a goal for further research.

It has now been shown that structural T1 weighted MR-images can be used to predict the response to a course of ECT via machine learning. Therefore, this study aims to use machine learning to predict the occurrence of episodic and specifically autobiographical memory deficits arising within a course of electroconvulsive therapy based on MR-images collected within one week before the first ECT treatment from severely depressed patients. Additionally, the neurophysiological correlates of the cognitive effects modulated by a course of ECT will be investigated longitudinally through the use of structural, resting-state and diffusion tensor images. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression.

If successful, this line of research should lead to a better tolerability of ECT by aiding in the complex decision making process involved in prescribing ECT as well as the parameter setting within a treatment course (e.g. uni- vs. bilateral).

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prediction of the Cognitive Effects of Electroconvulsive Therapy Via Machine Learning and Neuroimaging
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Group/Cohort Intervention/treatment
ECT Device: Electroconvulsive Therapy
Series of electroconvulsive therapy for major depressive disorder

Medication - Treatment as usual Drug: Medication - Treatment as usual
Medication only sample - Treatment as usual

Healthy controls



Primary Outcome Measures :
  1. Change in auditory verbal learning performance [ Time Frame: Within one week before first and one week after last ECT ]
    Auditory Verbal Learning Test (AVLT)

  2. Change in autobiographical memory performance [ Time Frame: Within one week before first and one week after last ECT ]
    Autobiographical Memory Interview (AMI-SF)

  3. Change in subjective memory impairment [ Time Frame: Within one week before first and one week after last ECT ]
    Qualitative Interview

  4. Occurence of retrograde amnesia [ Time Frame: Within the first week after last ECT ]

Secondary Outcome Measures :
  1. Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS 28). [ Time Frame: One week before first and one week after last ECT ]
    Hamilton Depression Rating Scale (HDRS 28). Remission defined as Hamilton Depression Rating Scale-28 score of less than or equal to 9 after the ECT course. Response defined as min. -50% change in Hamilton Depression Rating Scale-28 score after ECT.

  2. Change in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: One week before first and one week after last ECT ]
    Montgomery-Åsberg Depression Rating Scale (MADRS). Remission defined as Montgomery-Åsberg Depression Rating Scale score of less than or equal to 7 after the ECT course. Response defined as min. -50% change in Montgomery-Åsberg Depression Rating Scale score after ECT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490149


Contacts
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Contact: Maximilian Kiebs, M.Sc. 0049228287 ext 19710 m.kiebs@ukbonn.de

Locations
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Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
Contact: Maximilian Kiebs, M.Sc.    0228287 ext 19710    m.kiebs@ukbonn.de   
Sponsors and Collaborators
University Hospital, Bonn
Maximilian Kiebs, M.Sc. - University Hospital Bonn (Department of Medical Psychology)
Investigators
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Study Director: Rene Hurlemann, Prof. University Hospital, Bonn

Publications:

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Responsible Party: Rene Hurlemann, Prof. Dr. Dr., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT03490149    
Other Study ID Numbers: CoEffECT - Study
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rene Hurlemann, University Hospital, Bonn:
ECT
Electroconvulsive Therapy
Depression
Memory
Memory Impairment
Additional relevant MeSH terms:
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Depression
Cognitive Dysfunction
Behavioral Symptoms
Mental Disorders
Cognition Disorders
Neurocognitive Disorders