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Completed

NCT Number: NCT04189939

Computational Psychiatric Approach to 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinical assessments

Other

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):

Other names: computer-based decition making task, 3T MRI scan

Primary outcomes

  1. Functional Brain scanning - Neural activation

    Time frame: Baseline

    neural activation measured during functional MRI

  2. Functional Brain scanning - Neural activation

    Time frame: month 1

    neural activation measured during functional MRI

  3. Functional Brain scanning - Neural activation

    Time frame: month 2

    neural activation measured during functional MRI

Secondary outcomes

  1. Sensation Seeking Scale

    Time frame: Baseline, month 1, month 2

    This scale is a 43-item. Total score 0-430, higher number denotes worse outcomes.

  2. Perceived Control of Internal States Scale (PCISS)

    Time frame: 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.

  3. Montreal Cognitive Assessment

    Time frame: 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.

  4. Physical Risk Assessment Inventory

    Time frame: Baseline, month 1, month 2

    27 Items. Total score 0- 162, higher number denotes worse outcomes.

  5. Patient Health Questionnaire-9

    Time frame: 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.

  6. Hamilton Depression Inventory (HAM-D)

    Time frame: 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.

Other outcomes

  1. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: Baseline, month 1, month 2

    The SHAPS is a self-administered questionnaire with 14 items assessing domains of pleasure response/hedonic experience. Total score ranges from 0-42 with higher scores indicating increased anhedonia.

  2. Positive Valence Systems Scale (PVSS)

    Time frame: Baseline, month 1, month 2

    The PVSS is a self-administered 21-item questionnaire measuring the NIMH's Research Domain Criteria Positive Valence System Domain. Total score ranges from 1-189, with higher scores denoting increased response to rewards.

  3. Columbia Suicide Scale (C-SSRS)

    Time frame: Baseline, month 1, month 2

    The C-SSRS is designed to rate an individual's risk for suicide based on lifetime and recent ideations. Scores can range from no risk, low risk, moderate risk, and high risk.

  4. Apathy Motivation Index (AMI)

    Time frame: Baseline, month 1, month 2

    The AMI is an 18-item self-report index of apathy and motivation in Behavioral, Social, and Emotional Domains. Total score in each domain is 0-24 with higher scores denoting increased apathy.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Computational Psychiatric Approach for Prognosis of Medication-Resistant Depression

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2019
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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