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OpenTrials
Completed

NCT Number: NCT04348825

Electroconvulsive Therapy and Neuroradiology

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Electroconvulsive Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroconvulsive therapy

Device

Primary outcomes

  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 Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Acronym: ECTMRI

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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