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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04348825
Other study ID # 2013/1032
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2013
Est. completion date October 10, 2018

Study information

Verified date May 2020
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 10, 2018
Est. primary completion date September 19, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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. - 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 (according to the responsible clinician or ECT responsible). - Patients who cannot participate in the MRI scanning because of contraindications to MRI.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electroconvulsive therapy


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Haukeland University Hospital University of Bergen

References & Publications (1)

Oltedal L, Kessler U, Ersland L, Gruner R, Andreassen OA, Haavik J, Hoff PI, Hammar A, Dale AM, Hugdahl K, Oedegaard KJ. Effects of ECT in treatment of depression: study protocol for a prospective neuroradiological study of acute and longitudinal effects on brain structure and function. BMC Psychiatry. 2015 May 1;15:94. doi: 10.1186/s12888-015-0477-y. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters MRI of the brain is segmented into Regions of Interest by automated processing pipelines Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
Primary Changes from baseline in Depression ratings Symptoms scores on Montgomery-Åsberg Depression Rating Scale (MADRS) Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
Secondary Changes from baseline in Neurocognitive functioning Neurocognitive assessments Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
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