Using fMRI-neurofeedback to treat depression
Official title: A Randomised Controlled Trial of fMRI-neurofeedback in Depression
Run by Maastricht University Medical Center · NCT05640089 · Data updated 2026-11-12
This study is testing if adding brain training using fMRI-neurofeedback to regular treatment can help adults with depression feel better compared to just getting standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 3 sites (Maastricht and 2 other locations) |
| Status | Recruiting |
| Started | January 25, 2023 |
| Main results expected | April 30, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05640089 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with a depressive disorder who have been on stable antidepressant medication for at least four weeks.
✕Probably not a fit
Patients with a history of psychotic disorders, bipolar disorder, or those currently using illegal drugs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of fMRI-neurofeedback combined with standard care compared to standard care alone in adults with depression. Participants will be randomly assigned to receive either standard care or the neurofeedback intervention, which consists of five training sessions. The severity of depressive symptoms will be assessed at baseline, immediately after the intervention, and six months later to determine the impact of the neurofeedback training. The study employs a single-blind randomized controlled design to ensure unbiased assessment of outcomes.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients with depression, potentially leading to significant symptom reduction.
How similar studies have gone: Previous studies have shown promising results with fMRI-neurofeedback in depression, but this specific comparison with standard care has not been tested before.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Mondriaan Zorggroep
Maastricht, Netherlands Recruiting -
Maastricht University
Maastricht, Netherlands Recruiting -
Maastricht UMC+
Maastricht, Netherlands Recruiting
Study contacts
- Principal investigator: David E Linden, Prof. — Professor of Translational Neuroscience
- Study coordinator: David E Linden, Prof.
- Email: david.linden@maastrichtuniversity.nl
- Phone: +31 43 3881021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.