| NCT ID | NCT05640089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Depression, Unipolar |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief 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 weeks * Current 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 depression * Current use of illegal drugs (any in the last four weeks) * Current excessive alcohol consumption that interferes with daily functioning * History of neurological disease that could influence the fMRI signal and/or the anatomical alignment (e.g. territorial stroke, multiple sclerosis, brain tumour)
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