Status:
COMPLETED
Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 '...
Detailed Description
Major depressive disorder (MDD) is the world's largest health problem, and current available treatments fail at relieving symptoms for many patients. The best medical approach will depend on taking an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2024
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04138680
Start Date
October 9 2019
End Date
June 11 2024
Last Update
September 4 2024
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029