The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    150
  • sponsor
    Haukeland University Hospital
Updated on 2 December 2021
Accepts healthy volunteers

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).

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

Details
Condition Endogenous depression, healthy, Major depression, major depressive disorders, major depressive disorder, Major Depressive Disorder 1
Treatment rTMS, Electroconvulsive therapy
Clinical Study IdentifierNCT05135897
SponsorHaukeland University Hospital
Last Modified on2 December 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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