Repeated Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
Recruiting · NCT07694076 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Oxford
View the official record on ClinicalTrials.gov →Interventions studied
Active BiofeedbackSham Biofeedback
What this trial is about
Previous work demonstrated that individuals are able to self-regulate their ventral tegmental area (VTA) activity using real-time biofeedback. The current study expands this approach to a larger sample with repeated training sessions to more robustly characterize the effects of VTA modulation. The study will assess change in mood and motivation-related measures, as well as neural activity and connectivity changes.
Who can take part
Age range
18 Years to 65 Years
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
- Male or female aged 18-65 years;
- Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
Exclusion criteria
- Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, neurocognitive disorder or cognitive impairment
- Active substance use disorder within the past 1 year;
- Any unstable medical illnesses;
- Women who are pregnant;
- Any contraindications to MRI
- Antidepressant medication initiated within 2 weeks of the Baseline Assessment and concomitant use of any other medication with central nervous system activity during active participation;
- Active suicidal intent or plan.
Where it is running
1 location listed.
- Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital - Oxford, United Kingdom