DepressionNCT04189939
Computational Psychiatric Approach to Depression
An observational study of Depression and Treatment Resistant Depression, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Treatment Resistant Depression
- What is being tested?
- clinical assessments
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 10 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who meet the criteria in standard-of-care evaluation for ECT treatment, clinically depressed patients (non-treatment-resistant), and healthy adults.
Who may be able to join
- 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.
- Healthy adult volunteers (ages 18-85)
Who cannot join
- 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:
- Individuals diagnosed with depression (regardless of treatment status)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Computational Psychiatric Approach for Prognosis of Medication-Resistant 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.
Read the 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:
- 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.
- Conditions
- Depression, Treatment Resistant Depression
- Being tested
- clinical assessments
- Keywords
- ECT treatment, treatment-resistant depression, neural changes
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessmentsOther
Also called computer-based decition making task, 3T MRI scan
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):
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Brain scanning - Neural activation
neural activation measured during functional MRI
Measured: Baseline
Functional Brain scanning - Neural activation
neural activation measured during functional MRI
Measured: month 1
Functional Brain scanning - Neural activation
neural activation measured during functional MRI
Measured: month 2
Secondary outcomes (6)
Sensation Seeking Scale
This scale is a 43-item. Total score 0-430, higher number denotes worse outcomes.
Measured: 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.
Measured: 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.
Measured: Baseline, month 1, month 2
Physical Risk Assessment Inventory
27 Items. Total score 0- 162, higher number denotes worse outcomes.
Measured: 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.
Measured: 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.
Measured: Baseline, month 1, month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start9 Mar 2020
- Primary completion22 May 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth T Kishida, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189939
- Sponsor's protocol ID
- IRB00056131
- Status last verified
- Oct 2023
- First submitted
- 4 Dec 2019
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20797532Montague 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.
PubMed 22177032Wang 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.
PubMed 25442941Huys 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.
PubMed 26906507Berlim 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.
PubMed 17444078
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Psychiatric Approach for Prognosis of Medication-Resistant Depression
- ClinicalTrials.gov ID
- NCT04189939
- Acronym / sponsor ID
- IRB00056131
- Conditions
- Depression, Treatment Resistant Depression
- Keywords
- ECT treatment, treatment-resistant depression, neural changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subjects with treatment-resistant depression | – | Other: clinical assessmentsapproximately 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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the criteria in standard-of-care evaluation for ECT treatment, clinically depressed patients (non-treatment-resistant), and healthy adults.
Key inclusion criteria (4 listed)
- 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.
- Healthy adult volunteers (ages 18-85)
Key exclusion criteria (10 listed)
- 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
- Individuals diagnosed with depression (regardless of treatment status)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical assessmentsAlso: computer-based decition making task, 3T MRI scanBehavioral 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 | subjects with treatment-resistant depression |
Primary outcome
Functional Brain scanning - Neural activation
Time frame: Baseline
neural activation measured during functional MRI
Functional Brain scanning - Neural activation
Time frame: month 1
neural activation measured during functional MRI
Functional Brain scanning - Neural activation
Time frame: month 2
neural activation measured during functional MRI
6 secondary outcomes
Sensation Seeking Scale
Time frame: Baseline, month 1, month 2
Perceived Control of Internal States Scale (PCISS)
Time frame: Baseline, month 1, month 2
Montreal Cognitive Assessment
Time frame: Baseline, month 1, month 2
Physical Risk Assessment Inventory
Time frame: Baseline, month 1, month 2
Patient Health Questionnaire-9
Time frame: Baseline, month 1, month 2
Hamilton Depression Inventory (HAM-D)
Time frame: Baseline, month 1, month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 20797532Kishida 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.
- Background: PubMed 22177032Montague 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.
- Background: PubMed 25442941Wang 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.
- Background: PubMed 26906507Huys 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.
- Background: PubMed 17444078Berlim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth T Kishida, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Treatment Resistant Depression, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Brain scanning - Neural activation (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189939, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.