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Trial record 1 of 1 for:    ect and neuroradiology
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Electroconvulsive Therapy and Neuroradiology (ECTMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348825
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of ECT.

Condition or disease Intervention/treatment
Depression Electroconvulsive Therapy Device: Electroconvulsive therapy

Detailed Description:

As a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. The aim is to document both treatment effects and potential harmful effects of ECT.

Sample: n = 40 patients in a major depressive episode (bipolar and major depressive disorder). Two control groups with n = 15 in each group: age and gender matched healthy volunteers not receiving ECT and patients undergoing electrical cardioversion (ECV) for atrial fibrillation (AF). Observation time: six months.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients, depression
Patients who receive ECT as part of clinical care
Device: Electroconvulsive therapy
Healthy
Healthy controls who do not receive ECT but otherwise the same assessments.
Patients, atrial fibrilation
Patients who receive Electro Cardio Version (ECV) due to Atrial Fibrilation



Primary Outcome Measures :
  1. Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters [ Time Frame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) ]
    MRI of the brain is segmented into Regions of Interest by automated processing pipelines

  2. Changes from baseline in Depression ratings [ Time Frame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) ]
    Symptoms scores on MADRS


Secondary Outcome Measures :
  1. Changes from baseline in Neurocognitive functioning [ Time Frame: Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) ]
    Neurocognitive assessments


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population

Forty patients accepted for ECT at Haukeland University Hospital will be included.

Control groups: A group of patients undergoing Electrocardioversion (ECV) for atrial fibrilation (AF) (controls 1) and healthy controls undergoing the same investigations as the ECT patient group, but not receiving ECT or anesthesia (controls 2).

Criteria

Inclusion Criteria:

  • Patients (age > 18) referred to the ECT-unit and accepted for treatment because of moderate and severe depression, fulfilling the criteria for the following ICD-10 diagnoses: F31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3. In addition the symptom intensity must be verified by a score ≥ 25 on the Montgomery and Åsberg Depression Rating Scale (MADRS).

Exclusion Criteria:

  • ECT treatment within the last 12 months. Pregnancy. Patients unable to give written informed consent (ac- cording to the responsible clinician or ECT responsible). Patients who cannot participate in the MRI scanning because of contraindications to MRI.

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): NCT04348825


Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
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Principal Investigator: Ketil J Ødegaard, PhD Haukeland University Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04348825    
Other Study ID Numbers: 2013/1032
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms