Computational Psychiatric Approach to Depression

Study Overview
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Brief Summary
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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
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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: classify treatment resistant depression versus healthy controls and non-treatment resistant depression predictors of ECT treatment success versus failure characterize brain and behavioral changes consistent with treatment success versus failure predict who will need maintenance ECT therapy determine what changes in decision-making behavior are apparent in patients who require ECT maintenance therapy versus those who do not.

Official Title
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Computational Psychiatric Approach for Prognosis of Medication-Resistant Depression

Conditions
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Depression, Treatment Resistant Depression

Intervention / Treatment
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* Other: clinical assessments


Participation Criteria
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Eligibility Criteria
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For patients: Inclusion Criteria: Adult volunteers (ages 18-85) Treatment-resistant depressed patients must meet criteria in standard-of-care evaluation for ECT treatment Clinically depressed patients must meet criteria in standard-of-care evaluation for depression. 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 18-85) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects with treatment-resistant depression<br>approximately 48 subjects with treatment-resistant depression will undergo (1) clinical assessments, (2) perform a computer-based decision-making task while (3) their brain activity is monitored using a 3T MRI scanner. | Other: clinical assessments<br>* 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):<br>* Other names: 3T MRI scan;|
| healthy subjects<br>approximately 48 healthy subjects will undergo (1) clinical assessments, (2) perform a computer-based decision-making task while (3) their brain activity is monitored using a 3T MRI scanner. | |
| subjects with non treatment-resistant depression<br>approximately 48 subjects with non-treatment-resistant depression will undergo (1) clinical assessments, (2) perform a computer-based decision-making task while (3) their brain activity is monitored using a 3T MRI scanner. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Brain scanning - Neural activation | neural activation measured during functional MRI | Baseline | 
| Functional Brain scanning - Neural activation | neural activation measured during functional MRI | month 1 | 
| Functional Brain scanning - Neural activation | neural activation measured during functional MRI | month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensation Seeking Scale | This scale is a 43-item. Total score 0-430, higher number denotes worse outcomes. | Baseline, month 1, month 2 | 
| Perceived Control of Internal States Scale (PCISS) | The PCISS is an 18-item scale designed to measure respondents' perceptions of their ability to control their internal states and to moderate the impact of aversive events on their emotions, thoughts and physical well-being. Scores can range from 18 to 90, with high scores indicating higher levels of perceived control of internal states. | Baseline, month 1, month 2 | 
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal, the lower number denotes worse outcomes. | Baseline, month 1, month 2 | 
| Physical Risk Assessment Inventory | 27 Items. Total score 0- 162, higher number denotes worse outcomes. | Baseline, month 1, month 2 | 
| Patient Health Questionnaire-9 | The Patient Health Questionnaire (PHQ) is an instrument for making criteria-based diagnoses of depressive disorders commonly. Total score 1-29, higher scores denote worse severity of depression. | Baseline, month 1, month 2 | 
| Hamilton Depression Inventory (HAM-D) | The HAM-D is designed to rate the severity of depression in patients. Total score 0-54, higher scores denote worse severity of depression. | Baseline, month 1, month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECT treatment, treatment-resistant depression, neural changes