Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression

ID#: NCT04138680

Age: 18 - 65 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 09, 2019

End Date: December 01, 2022

Contact Information:
Grace Butler
(212) 585-4620
Summary: Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.
Eligibility: Inclusion Criteria Inclusion criteria for Subjects suffering from Depression:

- 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. Inclusion criteria for Healthy Control Subjects:

- Male or female aged 18-65 years;

- Does not meet for any current or past psychiatric diagnoses as defined by DSM-5 criteria as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);

- 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, or neurocognitive disorder for patients and for healthy control subjects: any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);

- Active substance use disorder within the past 6 months;

- Concomitant use of any medication with central nervous system activity within 1 week of scan;

- Positive urine toxicology screen for drugs of abuse at the time of screening;

- Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;

- Women who are pregnant;

- Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, inability to lie still for 1 hour or more, and inability to fit in the MRI scanner.

- Patients who are currently hospitalized on the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court ordered.
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