Computational Psychiatric Approach to Depression

Completed

Brief 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.

Recruitment & Eligibility

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

For healthy subject volunteers:

Inclusion Criteria:

Exclusion Criteria:

Arm && Interventions

Group	Intervention	Description
subjects with treatment-resistant depression	clinical assessments	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.

Primary Outcome Measures

Name	Time	Method
Functional Brain scanning - Neural activation	month 2	neural activation measured during functional MRI

Secondary Outcome Measures

Name	Time	Method
Sensation Seeking Scale	Baseline, month 1, month 2	This scale is a 43-item. Total score 0-430, higher number denotes worse outcomes.
Perceived Control of Internal States Scale (PCISS)	Baseline, month 1, month 2	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.
Montreal Cognitive Assessment	Baseline, month 1, month 2	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.
Physical Risk Assessment Inventory	Baseline, month 1, month 2	27 Items. Total score 0- 162, higher number denotes worse outcomes.
Patient Health Questionnaire-9	Baseline, month 1, month 2	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.
Hamilton Depression Inventory (HAM-D)	Baseline, month 1, month 2	The HAM-D is designed to rate the severity of depression in patients. Total score 0-54, higher scores denote worse severity of depression.

Locations (1): Wake Forest School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States