Investigating brain effects of depression treatments using advanced imaging
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
This study looks at how different depression treatments, like ECT and TMS, affect the brain using advanced imaging to see how well they work for people with major depressive disorder compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT05135897 on ClinicalTrials.gov |
What this trial studies
This observational study explores the neurobiological foundations of major depressive disorder by utilizing advanced magnetic resonance imaging (MRI) techniques. It aims to correlate imaging findings with psychiatric responses, neuropsychological functioning, and genetic biomarkers in patients undergoing electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). The study includes three groups: patients receiving ECT, patients receiving TMS, and healthy controls, with assessments conducted at multiple time points over six months to document treatment effects and potential side effects.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with moderate to severe major depressive disorder who are eligible for ECT or TMS.
Not a fit: Patients with mild depression or those not meeting the diagnostic criteria for major depressive disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of depression treatments and lead to improved therapeutic strategies.
How similar studies have performed: Other studies have shown promising results using similar neuroimaging approaches to understand the effects of depression treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ECT: * Patients (\>18) referred to the center of ECT and accepted for treatment * because of moderate and severe depression * fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3. * In addition, the symptom intensity must be verified by a MADRS score ≥ 25. * There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent). TMS: * Patients (\>18) referred to the center of TMS and accepted for treatment * because of moderate and severe depression * fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3. * In addition, the symptom intensity must be verified by a MADRS score ≥ 25. * There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent). Healthy controls: * Age and gender matched (to the patient groups). * No history of psychiatric illness and no current depression. * No contraindication for MRI scanning. Exclusion Criteria: * ECT / TMS treatment within the last 12 months. * Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible). * Patients who cannot participate in the MR scanning
Where this trial is running
Bergen, Vestland
- Haukeland University Hospital — Bergen, Vestland, Norway (Recruiting)
Study contacts
- Study coordinator: Leif Oltedal, PhD
- Email: leif.oltedal@uib.no
- Phone: +47 5597388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.