Reward Processing and Depressive Subtypes: Identifying Neural Biotypes

Sponsor
San Francisco Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT06080646
Collaborator
(none)
150
1
51
2.9

Study Details

Study Description

Brief Summary

Deficits in motivation and pleasure are common in depression, and thought to be caused by alterations in the ways in which the brain anticipates, evaluates, and adaptively uses reward-related information. However, reward processing is a complex, multi-circuit phenomenon, and the precise neural mechanisms that contribute to the absence or reduction of pleasure and motivation are not well understood. Variation in the clinical presentation of depression has long been a rule rather than an exception, including individual variation in symptoms, severity, and treatment response. This heterogeneity complicates understanding of depression and thwarts progress toward disease classification and treatment planning. Discovery of depression-specific biomarkers that account for neurobiological variation that presumably underlies distinct clinical manifestations is critical to this larger effort.

Condition or Disease Intervention/Treatment Phase
  • Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)

Detailed Description

This study combines clinically motivated questions with in-depth study of neurobiological mechanisms to evaluate how reward system neurobiology contributes to expression of reward-related deficits, such as decreased pleasure and motivation in major depressive disorder (MDD). Conceptually, the investigator will use a multi-measure approach, by studying basic brain responses to reward anticipation as well as higher-order aspects of reward processing necessary for decision-making.

Methodologically, the investigator will combine fMRI, EEG, and behavioral assessment, to more fully characterize reward-related brain functions and their clinical correlates. In addition to evaluating reward effects between MDD and healthy controls (HC), the investigator will also focus on understanding the relationship between reward processing and clinical features of high relevance to depression, with an emphasis on suicidality.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Reward Processing and Depressive Subtypes: Identifying Neural Biotypes Related to Suicide Risk, Resilience, and Treatment Response
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
MDD (Major Depressive Disorder) Group

Individuals (ages 18-70 years) who meet DSM-5 criteria for MDD, as assessed using the Structured Clinical Interview for DSM-5 (SCID-5), with Stable psychiatric medication regime for > 1 month will be recruited for participation in EEG and fMRI sessions in this observational study.

Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)
n/a there is no intervention in this observational study
Other Names:
  • cross-sectional MRI and EEG assessments
  • Unaffected Comparison Group

    50 unaffected comparison participants will be matched as a group to the age, race, educational level, handedness, and parental socio-economic status of the MDD patient group will be recruited for participation in EEG and fMRI testing sessions identical to those administered to the patients

    Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)
    n/a there is no intervention in this observational study
    Other Names:
  • cross-sectional MRI and EEG assessments
  • Outcome Measures

    Primary Outcome Measures

    1. Stimulus preceding negativity [1 month (EEG measure of reward anticipation)]

      Stimulus preceding negativity (EEG measure of reward anticipation) of reward-related brain activation patterns and EEG responses on participants

    2. Reward positivity [1 month (EEG measure of reward feedback)]

      Reward positivity (EEG measure of reward feedback) of reward-related brain activation patterns and EEG responses on participants

    3. Late positive potential [1 month (EEG measure of effective salience)]

      Late positive potential (EEG measure of affective salience) of reward-related brain activation patterns and EEG responses on participants

    4. fMRI response to win vs. loss reward feedback [1 month (fMRI data)]

      fMRI response to win vs. loss reward feedback of reward-related brain activation patterns and EEG responses on participants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18-70 years with a diagnosis of major depressive disorder (MDD) for MDD group, or without for unaffected comparison (UC) group

    • Negative metal screen for MRI safety

    • Normal (or corrected to normal) vision

    Exclusion Criteria:
    • • Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive symptoms)

    • Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic symptoms

    • Major medical conditions (e.g., seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)

    • Substance dependence, within the past year, or failed urine toxicology on the day of neuroimaging sessions

    • Known claustrophobia

    • Current Pregnancy

    • IQ estimate < 70

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Francisco Healthcare System San Francisco California United States 94121

    Sponsors and Collaborators

    • San Francisco Veterans Affairs Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susanna Fryer, PhD, Staff Psychologist/Clinician Investigator, San Francisco Veterans Affairs Medical Center
    ClinicalTrials.gov Identifier:
    NCT06080646
    Other Study ID Numbers:
    • CX001980
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Susanna Fryer, PhD, Staff Psychologist/Clinician Investigator, San Francisco Veterans Affairs Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2023