Computational Psychiatric Approach to Depression

NCT04189939 | Completed

• 1 other identifier: IRB00056131
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Treatment Resistant Depression

Keywords

ECT treatment; treatment-resistant depression; neural changes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Sensation Seeking Scale

  Baseline, month 1, month 2

• Perceived Control of Internal States Scale (PCISS)

  Baseline, month 1, month 2

• Montreal Cognitive Assessment

  Baseline, month 1, month 2

• Physical Risk Assessment Inventory

  Baseline, month 1, month 2

• Patient Health Questionnaire-9

  Baseline, month 1, month 2

Other Outcomes (4)

• Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline, month 1, month 2

• Positive Valence Systems Scale (PVSS)

  Baseline, month 1, month 2

• Columbia Suicide Scale (C-SSRS)

  Baseline, month 1, month 2

Study Arms (3)

subjects with treatment-resistant depression

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

healthy subjects

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

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.

Interventions

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):

Also known as: computer-based decition making task, 3T MRI scan

subjects with treatment-resistant depression

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the criteria in standard-of-care evaluation for ECT treatment, clinically depressed patients (non-treatment-resistant), and healthy adults.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Healthy adult volunteers (ages 18-85)
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• Kishida KT, King-Casas B, Montague PR. Neuroeconomic approaches to mental disorders. Neuron. 2010 Aug 26;67(4):543-54. doi: 10.1016/j.neuron.2010.07.021.

  PMID: 20797532 BACKGROUND

• Montague PR, Dolan RJ, Friston KJ, Dayan P. Computational psychiatry. Trends Cogn Sci. 2012 Jan;16(1):72-80. doi: 10.1016/j.tics.2011.11.018. Epub 2011 Dec 14.

  PMID: 22177032 BACKGROUND

• Wang XJ, Krystal JH. Computational psychiatry. Neuron. 2014 Nov 5;84(3):638-54. doi: 10.1016/j.neuron.2014.10.018. Epub 2014 Nov 5.

  PMID: 25442941 BACKGROUND

• Huys QJ, Maia TV, Frank MJ. Computational psychiatry as a bridge from neuroscience to clinical applications. Nat Neurosci. 2016 Mar;19(3):404-13. doi: 10.1038/nn.4238.

  PMID: 26906507 BACKGROUND

• Berlim MT, Turecki G. Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods. Can J Psychiatry. 2007 Jan;52(1):46-54. doi: 10.1177/070674370705200108.

  PMID: 17444078 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Kenneth T Kishida, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: March 9, 2020
• Primary Completion: May 22, 2023
• Study Completion: July 10, 2023
• Last Updated: August 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)