Clinical trial NCT04348825: Electroconvulsive Therapy and Neuroradiology
Official title: Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Electroconvulsive Therapy
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2020-04-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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.
* 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.

Primary outcomes:
measure: Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters
timeFrame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
measure: Changes from baseline in Depression ratings
timeFrame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
Secondary outcomes:
measure: Changes from baseline in Neurocognitive functioning
timeFrame: Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Haukeland University Hospital
name: Ketil J Ødegaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Blomberg MO, Semkovska M, Kessler U, Erchinger VJ, Oedegaard KJ, Oltedal L, Hammar A. A Longitudinal Comparison Between Depressed Patients Receiving Electroconvulsive Therapy and Healthy Controls on Specific Memory Functions. Prim Care Companion CNS Disord. 2020 May 14;22(3):19m02547. doi: 10.4088/PCC.19m02547.