Using fMRI-neurofeedback to treat depression
A Randomised Controlled Trial of FMRI-neurofeedback in Depression
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 3 sites (Maastricht and 2 other locations) |
| Trial ID | NCT05640089 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a history of psychotic disorders, bipolar disorder, or those currently using illegal drugs may not benefit from this study.
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 performed: Previous studies have shown promising results with fMRI-neurofeedback in depression, but this specific comparison with standard care has not been tested before.
Eligibility criteria
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 this trial is running
Maastricht and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.