NCT04189939

Computational Psychiatric Approach to Depression

Computational Psychiatric Approach for Prognosis of Medication-Resistant Depression

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Depression
• Treatment Resistant Depression

Interventions

Type	Name	Description
OTHER	clinical assessments	Behavioral tasks will be executed via a computer interface. Below, we provide an estimated timeline for each visit and subsequently provide detail for the relevant stages. Each participant's visit will last approximately 4-5 hours. Each visit will consist of the following tasks (in this order):

Timeline

• Start date: 2020-03-09
• Primary completion: 2023-05-22
• Completion: 2023-07-10
• First posted: 2019-12-06
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States