NCT05135897

The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).

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 and TMS Sample, three groups: ECT: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with ECT. TMS: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with TMS. HC: = 50 age and gender matched healthy volunteers not receiving ECT nor TMS. Observation time: six months, with the time points as specified below. ECT is typically given three times weekly, but exceptions may occur. Hence, time points are specified as the number of ECT treatments given rather than an exact number of days which will vary. Tp1: 2 hours before the first treatment session (day 1, baseline), Tp2: 2 hours after the first treatment session (day 1), Tp3: before the 7th ECT session and corresponding time point for TMS (\~ day 15), Tp4: 1-2 weeks after last treatment session (\~ day 30 - 50), Tp5: 6 months after treatment (\~ day 180), Healthy controls are only assessed at Tp1,2,4,5

Conditions

• Major Depressive Disorder 1
• Major Depressive Disorder
• Healthy

Interventions

Type	Name	Description
DEVICE	Electroconvulsive therapy	Treatment with Electroconvulsive therapy
DEVICE	rTMS	repetitive Transcranial Magnetic Stimulation

Timeline

• Start date: 2021-09-27
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-11-26
• Last updated: 2021-11-26

Locations

1 site across 1 country: Norway