Depression Clinical Trial
— ECTMRIOfficial title:
Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function
Verified date | May 2020 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of ECT.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 10, 2018 |
Est. primary completion date | September 19, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients (age > 18) referred to the ECT-unit and accepted for treatment because of moderate and severe depression, - fulfilling the criteria for the following ICD-10 diagnoses: F31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3. - symptom intensity must be verified by a score = 25 on the Montgomery and Åsberg Depression Rating Scale (MADRS). Exclusion Criteria: - ECT treatment within the last 12 months. - Pregnancy. - Patients unable to give written informed consent (according to the responsible clinician or ECT responsible). - Patients who cannot participate in the MRI scanning because of contraindications to MRI. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Oltedal L, Kessler U, Ersland L, Gruner R, Andreassen OA, Haavik J, Hoff PI, Hammar A, Dale AM, Hugdahl K, Oedegaard KJ. Effects of ECT in treatment of depression: study protocol for a prospective neuroradiological study of acute and longitudinal effects on brain structure and function. BMC Psychiatry. 2015 May 1;15:94. doi: 10.1186/s12888-015-0477-y. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters | MRI of the brain is segmented into Regions of Interest by automated processing pipelines | Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) | |
Primary | Changes from baseline in Depression ratings | Symptoms scores on Montgomery-Åsberg Depression Rating Scale (MADRS) | Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) | |
Secondary | Changes from baseline in Neurocognitive functioning | Neurocognitive assessments | Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) |
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