Condition: Depressive Disorder, Major · Sponsor: Medical University of Vienna
Despite its successful use for more than 80 years, the mechanisms of action of electroconvulsive therapy (ECT) are still not fully understood. ECT has been shown to be accompanied by changes in regional brain volumes and connectivity measures, as well as biochemical alterations. However, how these changes relate to ECT response remains to be further elucidated; up to now, there are no objective markers for the targeted use of ECT in clinical practice. Methods: Study design: longitudinal mono-centre study with duration of 36 months. Subjects: 30 depressed patients (aged 18-65 years) eligible for ECT. Measurements: subjects will undergo 2 3-Tesla MRI scans (one before and one after a course of ECT), including structural MRI, resting-state functional MRI, task-based functional MRI and MR spectroscopy. Blood, CSF sampling and clinical assessments will be performed once before and once after the ECT course. ECT: Each patient will be treated in a min. of 8 bitemporal ECT sessions (\~4 weeks). Data analysis: Longitudinal changes in brain imaging parameters and laboratory measures (before/after ECT) will be assessed using repeated-measures analysis of covariance. Machine learning with random forests will be employed to identify a pattern of pretreatment imaging, biochemical (serum and CSF) and clinical parameters that are best qualified to predict response to ECT as defined by a reduction of ≥50% of baseline HAMD17. Hypotheses: 1. ECT will be accompanied by changes in brain morphol…
This description comes directly from the study's public registry record.
Pia Baldinger-Melich, MD, PhD, PD, Assoc.Prof. · +43 1 40400 35350 · pia.baldinger-melich@meduniwien.ac.at
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| Department of Psychiatry and Psychotherapy, Medical University of Vienna | Vienna, Austria | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05630469