Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
128 participants
OBSERVATIONAL
2020-03-09
2023-07-10
Brief Summary
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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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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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):
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Interventions
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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):
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Healthy adult volunteers (ages 18-85)
Exclusion Criteria
* 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:
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Kenneth T Kishida, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IRB00056131
Identifier Type: -
Identifier Source: org_study_id
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