Electroconvulsive Therapy and Neuroradiology

Depression Clinical Trial

— ECTMRI  

Official title:

Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348825
• Other study ID #: 2013/1032
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Electroconvulsive Therapy

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)