Winston-Salem, North Carolina 27157

  • Depression

Purpose:

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) he/she is a patient about to receive ECT treatment for depression, or (2) he/she is a healthy adult volunteer with no history of depression. All volunteers must be between ages 18-70. Participation in this research will involve three visits. Each visit will last about 4-5 hours. If subject is a patient receiving ECT for depression the study team will schedule study visits to go along with patient treatment visits. If subject is a healthy volunteer, visits will occur 1 month and 2 months after the initial visit. Participation in this research will involve playing simple computer games while subject's brain is scanned with magnetic resonance imaging (MRI). Additionally, 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 volunteers will not undergo ECT treatment.


Study summary:

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 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.


Criteria:

For subject volunteers with depression: Inclusion Criteria: - Adult volunteers (ages 18-70) - Patients must meet criteria in standard-of-care evaluation for ECT treatment. Exclusion Criteria: - Individuals who cannot have MRI scanning - Individuals not able to provide written consent and verbal assent - Individuals not able to understand task instructions or consent documents - Women who are pregnant For healthy subject volunteers: Inclusion Criteria: - Healthy adult volunteers (ages 18-70) Exclusion Criteria: - Individuals diagnosed with depression (regardless of treatment status) - Individuals who cannot have MRI scanning - Individuals not able to provide written consent and verbal assent - Individuals not able to understand task instructions or consent documents - Women who are pregnant


NCT ID:

NCT04189939


Primary Contact:

Principal Investigator
Kenneth T Kishida, PhD
Wake Forest University Health Sciences

Rachel Jones, MS
Phone: 336-716-8580
Email: rachjone@wakehealth.edu


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States

Rachel Jones, MS
Email: rachjone@wakehealth.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 01, 2022

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