The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

NCT05135897 | Unknown

• 1 other identifier: 254425
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder 1; Major Depressive Disorder; Healthy

Outcome Measures

Primary Outcomes (2)

• Change in Cerebral Blood Flow from baseline

  Estimated by Arterial Spin Labeling MRI

  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)

• Change in MADRS from baseline

  Depression rating by MADRS score

  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 (5)

• Change fraction of in Isotropic hindered water

  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)

• Change in concentration of NAA, Choline, myo Inositol

  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)

• Changes in structural MRI T1 and T2 and RSI

  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)

• Changes in functional MRI

  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)

• Change in performance on test of spatial navigation

  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)

Study Arms (3)

Patients, depression, ECT

Patients in major depressive episode undergoing ECT

Device: Electroconvulsive therapy

Patients, depression, TMS

Patients in major depressive episode undergoing TMS

Device: rTMS

Healthy

Healthy controls who do not receive ECT nor TMS but otherwise the same assessments.

Interventions

Electroconvulsive therapy DEVICE

Treatment with Electroconvulsive therapy

Patients, depression, ECT

rTMS DEVICE

repetitive Transcranial Magnetic Stimulation

Patients, depression, TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• 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.
• Healthy controls:
• Age and gender matched (to the patient groups).
• No history of psychiatric illness and no current depression.
• No contraindication for MRI scanning.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

Related Publications (1)

• Frid LM, Kessler U, Ousdal OT, Hammar A, Haavik J, Riemer F, Hirnstein M, Ersland L, Erchinger VJ, Ronold EH, Nygaard G, Jakobsen P, Craven AR, Osnes B, Alisauskiene R, Bartsch H, Le Hellard S, Stavrum AK, Oedegaard KJ, Oltedal L. Neurobiological mechanisms of ECT and TMS treatment in depression: study protocol of a multimodal magnetic resonance investigation. BMC Psychiatry. 2023 Oct 30;23(1):791. doi: 10.1186/s12888-023-05239-0.

  PMID: 37904091 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Major Depressive Disorder 1; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Leif Oltedal, PhD

CONTACT

+47 5597388; leif.oltedal@uib.no

Leila Fried, Master

CONTACT

+47 55974513; leila.frid@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 26, 2021
• Study Start: September 27, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 26, 2021

Record last verified: 2021-10

Locations

NO (1)