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NCT05640089
FMRI-neurofeedback in Depression
Conditions: Depression, Unipolar
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Maastricht University
Location: Netherlands
Summary
Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction.
The goal of this clinical trial is to compare fMRI-neurofeedback plus standard care with standard care in patients with depression.Participants will either receive standard care, or standard care plus a fMRI neurofeedback training, consisting of 5 neurofeedback training sessions.
Symptom severity will be assessed before, immediately after and 6 months after the intervention.
Eligibility Criteria
Inclusion Criteria:Diagnosis of a depressive disorder (ICD-10: F32 or F33)Has been on stable antidepressant medication (single or combination treatment) for at least 4 weeksCurrent depression (QIDS >= 17)If required to meet recruitment targets the minimum entry score will be reduced QIDS >= 13 (i.e.
still corresponding to a moderate level of depression)Exclusion Criteria:Exclusion criteria for MRI (e.g.
cardiac pacemaker, certain metallic implants)History of psychotic disorder bipolar disorder, or psychotic depressionCurrent use of illegal drugs (any in the last four weeks)Current excessive alcohol consumption that interferes with daily functioningHistory of neurological disease that could influence the fMRI signal and/or the anatomical alignment (e.g.
territorial stroke, multiple sclerosis, brain tumour)
Source: ClinicalTrials.gov (NCT05640089). StuddyBuddy aggregates publicly available trial information.