Major Depressive DisorderNCT03203954
Testing the Neuroscience of Guided Learning in Depression
A study testing Standard Learning, Guided Learning: Instructed statistics and Guided Learning: Changing statistics in people with Major Depressive Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Major depression is a prevalent and impairing illness. To better understand the basic science and treatment of depression, the investigators study the behavioral and brain processes associated with learning in depression and how potential disruptions in learning may be repaired. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Standard Learning, Guided Learning: Instructed statistics and Guided Learning: Changing statistics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to Dec 2021
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females of all ethnicities
- meet diagnostic criteria for major depression or non-depressed control (assessed by study staff)
- ages 18-55
- fluent in English
- able to see computer display clearly
- able to provide informed consent
- able to follow verbal or written instructions
- for participants who are referred by a clinician, a letter from that clinician indicating that participation in the study does not constitute an elevated medical or behavioral risk to the participant will be requested.
Who cannot join
- current pregnancy or menopause
- claustrophobia
- MRI contraindications
- psychotic or bipolar disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Tech Carilion Research Institute
Roanoke, Virginia, 24016
About this study
Official title: Neural Substrates of Reinforcement Learning and Its Training in Major Depression
Major depression is a prevalent and impairing illness. To better understand the basic science and treatment of depression, the investigators study the behavioral and brain processes associated with learning in depression and how potential disruptions in learning may be repaired. Understanding different methods that change learning may lead to novel treatments that contribute to recovery in people with depression.
Read the detailed description
Major depressive disorder ranks among the most significant causes of mortality and disability in the world. Recent data from the investigators and others highlight that impairments in reward and loss learning are central to depression, have distinct neural substrates, and improve with successful treatment. Together, these findings suggest an urgent need to delineate the relationships among neural and behavioral learning impairments and depression. Equally important, these insights suggest new targets for treatment such that manipulating the neural and behavioral substrates of learning may facilitate symptom change in depression.
To address these issues, the investigators use functional neuroimaging and a computational psychiatry framework to i) systematically characterize the neural and behavioral substrates that attend reward- and loss- learning in depression and ii) assess the degree to which learning in depression responds to two behavioral methods that target learning in different ways. The investigators test the broad hypotheses that i) that depression may be characterized by distinct neural and behavioral disruptions of learning, and ii) these disruptions and associated symptoms may be ameliorated through different methods of guiding learning. Recent advances in computational psychiatry provide a mechanism-based framework within which to understand the nature and trajectory of potential learning impairments in depression and suggest new ways that disrupted learning and associated symptoms may be improved in depression
- Conditions
- Major Depressive Disorder
- Being tested
- Standard Learning, Guided Learning: Instructed statistics, Guided Learning: Changing statistics
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard LearningBehavioural
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Guided Learning: Instructed statisticsBehavioural
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Guided Learning: Changing statisticsBehavioural
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| No Training | Active comparator | Guided learning, standard learning: Repeat administration of standard behavioral learning task Receives: Behavioral: Standard Learning |
| Instructed Statistics | Experimental | Guided learning, instructed statistics: Repeat administration of behavioral learning task with instructions about task statistics Receives: Behavioral: Guided Learning: Instructed statistics |
| Not Instructed Statistics | Experimental | Guided learning, changing statistics: Repeat administration of behavioral learning task with changing task statistics Receives: Behavioral: Guided Learning: Changing statistics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task performance
behavioral measures of learning task performance including accuracy, learning rate
Measured: approximately 6 weeks (pre- post- learning task changes and interim time points)
Secondary outcomes (2)
Neuroimaging measures
functional MRI during learning task performance
Measured: approximately 6 weeks (pre- post- learning task changes and interim time points)
Symptoms
self-report questionnaires and clinician-obtained symptom measures
Measured: approximately 6 weeks (pre- post- learning task changes and interim time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 May 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Pearl Chiu, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203954
- Sponsor's protocol ID
- MDDLEARNING
- Other IDs
- R01MH106756
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2017
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: following study completion, de-identified data will be made available to approved researchers and may be requested from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Substrates of Reinforcement Learning and Its Training in Major Depression
- ClinicalTrials.gov ID
- NCT03203954
- Acronym / sponsor ID
- MDDLEARNING
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 29 Jun 2017 (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.
Major depression is a prevalent and impairing illness. To better understand the basic science and treatment of depression, the investigators study the behavioral and brain processes associated with learning in depression and how potential disruptions in learning may be repaired. Understanding different methods that change learning may lead to novel treatments that contribute to recovery in people with depression.
Detailed description
Major depressive disorder ranks among the most significant causes of mortality and disability in the world. Recent data from the investigators and others highlight that impairments in reward and loss learning are central to depression, have distinct neural substrates, and improve with successful treatment. Together, these findings suggest an urgent need to delineate the relationships among neural and behavioral learning impairments and depression. Equally important, these insights suggest new targets for treatment such that manipulating the neural and behavioral substrates of learning may facilitate symptom change in depression.
To address these issues, the investigators use functional neuroimaging and a computational psychiatry framework to i) systematically characterize the neural and behavioral substrates that attend reward- and loss- learning in depression and ii) assess the degree to which learning in depression responds to two behavioral methods that target learning in different ways. The investigators test the broad hypotheses that i) that depression may be characterized by distinct neural and behavioral disruptions of learning, and ii) these disruptions and associated symptoms may be ameliorated through different methods of guiding learning. Recent advances in computational psychiatry provide a mechanism-based framework within which to understand the nature and trajectory of potential learning impairments in depression and suggest new ways that disrupted learning and associated symptoms may be improved in depression
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Training | Active comparator | Behavioral: Standard LearningGuided learning, standard learning: Repeat administration of standard behavioral learning task |
| Instructed Statistics | Experimental | Behavioral: Guided Learning: Instructed statisticsGuided learning, instructed statistics: Repeat administration of behavioral learning task with instructions about task statistics |
| Not Instructed Statistics | Experimental | Behavioral: Guided Learning: Changing statisticsGuided learning, changing statistics: Repeat administration of behavioral learning task with changing task statistics |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- males and females of all ethnicities
- meet diagnostic criteria for major depression or non-depressed control (assessed by study staff)
- ages 18-55
- fluent in English
- able to see computer display clearly
Key exclusion criteria (4 listed)
- current pregnancy or menopause
- claustrophobia
- MRI contraindications
- psychotic or bipolar disorder
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 |
|---|---|---|
| Standard LearningParticipants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed. | Behavioural | No Training |
| Guided Learning: Instructed statisticsParticipants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed. | Behavioural | Instructed Statistics |
| Guided Learning: Changing statisticsParticipants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed. | Behavioural | Not Instructed Statistics |
Primary outcome
Task performance
Time frame: approximately 6 weeks (pre- post- learning task changes and interim time points)
behavioral measures of learning task performance including accuracy, learning rate
2 secondary outcomes
Neuroimaging measures
Time frame: approximately 6 weeks (pre- post- learning task changes and interim time points)
Symptoms
Time frame: approximately 6 weeks (pre- post- learning task changes and interim time points)
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 8 Jul 2022.
- Individual participant dataSharing planned: Yes. following study completion, de-identified data will be made available to approved researchers and may be requested from the principal investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Learning, Guided Learning: Instructed statistics and Guided Learning: Changing statistics in people with Major Depressive Disorder, run by Virginia Polytechnic Institute and State University 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 8 inclusion and 4 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 8 Jul 2022. 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?
Task performance (time frame: approximately 6 weeks (pre- post- learning task changes and interim time points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2022.