Testing the Neuroscience of Guided Learning in Depression

Major Depressive Disorder Clinical Trial

Official title:

Neural Substrates of Reinforcement Learning and Its Training in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203954
• Other study ID #: MDDLEARNING
• Secondary ID: R01MH106756
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 2021

Study information

• Verified date: July 2022
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Understanding different methods that change learning may lead to novel treatments that contribute to recovery in people with depression.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• current pregnancy or menopause
• claustrophobia
• MRI contraindications
• psychotic or bipolar disorder

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Standard Learning
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
• Guided Learning: Instructed statistics
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
• Guided Learning: Changing statistics
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Locations

Country	Name	City	State
United States	Virginia Tech Carilion Research Institute	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Task performance	behavioral measures of learning task performance including accuracy, learning rate	approximately 6 weeks (pre- post- learning task changes and interim time points)
Secondary	Neuroimaging measures	functional MRI during learning task performance	approximately 6 weeks (pre- post- learning task changes and interim time points)
Secondary	Symptoms	self-report questionnaires and clinician-obtained symptom measures	approximately 6 weeks (pre- post- learning task changes and interim time points)