Reward Processing and Depressive Subtypes: Identifying Neural Biotypes

NCT06080646 | Recruiting

• 1 other identifier: CX001980
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Disorder; Major Depressive Disorder; Major Depressive Episode; Depressive Symptoms; Anhedonia

Keywords

reward; motivation; EEG; fMRI; MRI; functional MRI; amotivation; avolition; suicidality; suicide

Outcome Measures

Primary Outcomes (4)

• Stimulus preceding negativity

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

  1 month (EEG measure of reward anticipation)

• Reward positivity

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

  1 month (EEG measure of reward feedback)

• Late positive potential

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

  1 month (EEG measure of effective salience)

• fMRI response to win vs. loss reward feedback

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

  1 month (fMRI data)

Study Arms (2)

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)

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)

Interventions

cross-sectional MRI and EEG assessments (NO INTERVENTION) OTHER

n/a there is no intervention in this observational study

Also known as: cross-sectional MRI and EEG assessments

MDD (Major Depressive Disorder) Group; Unaffected Comparison Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Major Depressive Disorder (age range 18 - 70)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead

Study Sites (1)

San Francisco Healthcare System

San Francisco, California, 94121, United States

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major; Anhedonia; Suicidal Ideation; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Injurious Behavior

Study Officials

• Susanna L Fryer, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Hemmerle, MBA

CONTACT

415 221 4810; jason.hemmerle@ucsf.edu

Kaitlyn Dal Bon, BA

CONTACT

415 221 4810; kaitlyn.dalbon@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist/Clinician Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 12, 2023
• Study Start: June 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)