NCT05640089Recruiting
FMRI-neurofeedback in Depression
A Randomised Controlled Trial of fMRI-neurofeedback in Depression
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 28 Nov 2022
- Start date
- 25 Jan 2023
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Depression
- NCT number
- NCT05640089
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 25 Jan 2023 to the primary completion date, 30 Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of illegal drugs (any in the last four weeks)
Other illness
- Exclusion criteria for MRI (e.g. cardiac pacemaker, certain metallic implants)
- History of psychotic disorder bipolar disorder, or psychotic depression
- History of neurological disease that could influence the fMRI signal and/or the anatomical alignment (e.g. territorial stroke, multiple sclerosis, brain tumour)
Other
- Current excessive alcohol consumption that interferes with daily functioning
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Mondriaan Zorggroep Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.