VTA real-time biofeedback with 7-Tesla MRI in depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This mechanistic study will enroll 60 adults with major depressive disorder and randomize them to active or sham real-time biofeedback while they attempt to self-regulate ventral tegmental area activity using cognitive strategies during 7T MRI sessions. Participants will complete two training sessions with feedback while viewing visual cues, aiming to characterize changes in mood, motivation-related measures, and neural connectivity. The trial builds on prior work showing VTA self-regulation is feasible and seeks to clarify relationships between targeted VTA modulation and clinical/neural outcomes in a larger sample. Outcomes will include mood and motivation scales as well as fMRI-derived measures of brain activity and functional connectivity.

Why it matters

Who can join: the full rules

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; as conducted in a research-based non-clinical setting.
* 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's running

• Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital
  Oxford, United Kingdom Recruiting

Study contacts

• Principal investigator: Laurel S Morris, Dr — University of Oxford
• Study coordinator: Laurel S Morris, Dr
• Email: laurel.morris@ndcn.ox.ac.uk
• Phone: 01865 (6)16577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.