The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
NCT ID: NCT05135897
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-09-27
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients, depression, ECT
Patients in major depressive episode undergoing ECT
Electroconvulsive therapy
Treatment with Electroconvulsive therapy
Patients, depression, TMS
Patients in major depressive episode undergoing TMS
rTMS
repetitive Transcranial Magnetic Stimulation
Healthy
Healthy controls who do not receive ECT nor TMS but otherwise the same assessments.
No interventions assigned to this group
Interventions
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Electroconvulsive therapy
Treatment with Electroconvulsive therapy
rTMS
repetitive Transcranial Magnetic Stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible).
* Patients who cannot participate in the MR scanning
18 Years
ALL
Yes
Sponsors
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University of Bergen
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Locations
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Haukeland University Hospital
Bergen, Vestland, Norway
Countries
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Central Contacts
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Facility Contacts
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Leila Frid
Role: primary
References
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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.
Other Identifiers
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254425
Identifier Type: -
Identifier Source: org_study_id