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Search / Trial NCT05135897

The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

Launched by HAUKELAND UNIVERSITY HOSPITAL · Nov 16, 2021

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how depression affects the brain and how certain treatments, like electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), can help relieve symptoms. Researchers will use advanced MRI technology to look at changes in the brain's structure and function in people undergoing these treatments. The goal is to better understand the neurobiological basis of depression and how these therapies work.

To participate in the trial, individuals must be over 18 years old and diagnosed with moderate to severe depression, as confirmed by their doctor. They will need to meet specific criteria based on their diagnosis and show a certain level of symptom severity. Healthy participants will also be included in the study for comparison, but they must not have any history of mental health issues. Participants can expect to undergo MRI scans and receive one of the treatments being studied. Importantly, those who have had ECT or rTMS in the past year, or who cannot give informed consent, will not be eligible to join. This trial aims to enhance our understanding of depression and improve treatment options for individuals who are struggling.

Gender

ALL

Eligibility 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

About Haukeland University Hospital

Haukeland University Hospital, located in Bergen, Norway, is a leading academic medical center renowned for its commitment to innovative research and high-quality patient care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in various medical fields to facilitate cutting-edge clinical studies that aim to advance healthcare outcomes. With a multidisciplinary team of healthcare professionals and researchers, Haukeland University Hospital fosters collaboration and knowledge exchange, ensuring that trials are conducted with the highest standards of ethics, safety, and scientific rigor. Its strategic focus on translational research enhances the bridge between laboratory discoveries and real-world applications, contributing to the global body of medical knowledge.

Locations

Bergen, Vestland, Norway

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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