The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

Healthy Clinical Trial

— FundECT  

Official title:

The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135897
• Other study ID #: 254425
• Status: Recruiting
• Start date: September 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2021
• Source: Haukeland University Hospital
• Contact: Leif Oltedal, PhD
• Phone: +47 5597388
• Email: leif.oltedal[@]uib.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Healthy
• Major Depressive Disorder
• Major Depressive Disorder 1

Intervention

Device:
• Electroconvulsive therapy
Treatment with Electroconvulsive therapy
• rTMS
repetitive Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestland

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change fraction of in Isotropic hindered water	Measured by Restriction spectrum imaging. Increase in the fraction of isotropic hindered water as a sign of oedema / disruptive effects of ECT seen on Imaging at 2 hours after first ECT.	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	Change in concentration of NAA, Choline, myo Inositol	MR Spectroscopy og the amygdala, measures of neuronal integrity.	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	Changes in structural MRI T1 and T2 and RSI	Measures of brain structure	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	Changes in functional MRI	Resting state MRI, measurement of functional connectivity	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	Change in performance on test of spatial navigation	Neurocognitive assessments 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)