RecruitingNot ApplicableNCT05640089

FMRI-neurofeedback in Depression

A Randomised Controlled Trial of FMRI-neurofeedback in Depression

Sponsor

Maastricht University Medical Center

Enrollment

120 participants

Start Date

Jan 25, 2023

Study Type

INTERVENTIONAL

Conditions

Depression, Unipolar

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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)

Interventions

OTHERfMRI-based neurofeedback

Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).