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RECRUITING Not applicable ClinicalTrials.gov

FMRI-neurofeedback in Depression

Sponsor: Maastricht University Medical Center • ClinicalTrials.gov ID: NCT05640089

Registry updated: 2026-10-13
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Description

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.

Interventions

  • fMRI-based neurofeedback (Other)
    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).

Eligibility 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)

Conditions

Depression, Unipolar

Locations

  • Mondriaan Zorggroep — Maastricht, Netherlands
  • Maastricht University — Maastricht, Netherlands
  • Maastricht UMC+ — Maastricht, Netherlands
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record