Clinical trial NCT05135897: The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Official title: The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder 1
Major Depressive Disorder
Healthy
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2021-11-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients accepted for ECT or TMS at Haukeland University Hospital will be included.

Control groups: Healthy controls undergoing the same investigations as the ECT and TMS patient groups, but not receiving any treatment

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 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

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

Primary outcomes:
measure: Change in Cerebral Blood Flow from baseline
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
measure: Change in MADRS from baseline
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Secondary outcomes:
measure: Change fraction of in Isotropic hindered water
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
measure: Change in concentration of NAA, Choline, myo Inositol
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
measure: Changes in structural MRI T1 and T2 and RSI
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
measure: Changes in functional MRI
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
measure: Change in performance on test of spatial navigation
timeFrame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Vestland
Study officials:
References: