FMRI-neurofeedback in Depression
Recruiting · NCT05640089 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
fMRI-based neurofeedback
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
3 locations listed.
- Mondriaan Zorggroep - Maastricht, Netherlands
- Maastricht University - Maastricht, Netherlands
- Maastricht UMC+ - Maastricht, Netherlands