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Computational Psychiatric Approach for Prognosis of Medication-Resistant Depression
The purpose of this research is to investigate how the brain changes in patients undergoing electroconvulsive (ECT) treatment for depression. Subjects will be invited to be in this study because (1) they are a patient about to receive ECT treatment for depression, or (2) they are a patient diagnosed with depression and do not qualify for ECT treatment, or (3) they are a healthy adult volunteer with no history of depression. All volunteers must be between the ages of 18-85. Participation in this research will involve three visits. Each visit will last about 3-4 hours. If the subject is a patient receiving ECT for depression the study team will schedule study visits to go along with patient treatment visits. If the subject is diagnosed with depression (not treatment-resistant depression) or are a healthy volunteer, their first visit will be scheduled at their convenience, followed by a second visit 1-3 months post visit one and a third visit 1-2 months post visit two, for a total of three research visits. Participation in this research will involve playing simple computer games while the subject's brain is scanned with magnetic resonance imaging (MRI). Additionally, the study team will assess symptoms of depression using questionnaires. Patients receiving ECT will not experience any changes to their standard of care ECT treatment plan. Healthy and non-treatment resistant depressed volunteers will not undergo ECT treatment.
The goal for this study will be to test the following overall hypotheses: (1) that adaptive decision-making processes are disrupted in patients with treatment-resistant depression, and (2) the neural and behavioral changes associated with treatment-resistant depression can be assessed using functional magnetic resonance imaging paired with computationally constrained adaptive decision-making games. The investigators will use computational modeling of incentivized decision-making tasks, brain imaging (functional magnetic resonance imaging, fMRI), and standard clinical assessments, to characterize patients referred to Wake Forest Baptist Medical Center for ECT. Characterization will occur over multiple visits to be aligned with the normal course of patient care. Data collected may be used in hypothesis driven analyses to: 1. classify treatment resistant depression versus healthy controls and non-treatment resistant depression 2. predictors of ECT treatment success versus failure 3. characterize brain and behavioral changes consistent with treatment success versus failure 4. predict who will need maintenance ECT therapy 5. determine what changes in decision-making behavior are apparent in patients who require ECT maintenance therapy versus those who do not.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
Yes
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Start Date
March 9, 2020
Primary Completion Date
May 22, 2023
Completion Date
July 10, 2023
Last Updated
August 6, 2024
128
ACTUAL participants
clinical assessments
OTHER
Lead Sponsor
Wake Forest University Health Sciences
NCT07360600
NCT06793397
Data Source & Attribution
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