Reward Processing and Depressive Subtypes: Identifying Neural Biotypes

NCT ID: NCT06080646

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

cross-sectional MRI and EEG assessments (NO INTERVENTION)

Intervention Type OTHER

n/a there is no intervention in this observational study

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

cross-sectional MRI and EEG assessments (NO INTERVENTION)

Intervention Type OTHER

n/a there is no intervention in this observational study

Interventions

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cross-sectional MRI and EEG assessments (NO INTERVENTION)

n/a there is no intervention in this observational study

Intervention Type OTHER

Other Intervention Names

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cross-sectional MRI and EEG assessments

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Francisco Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Susanna Fryer, PhD

Staff Psychologist/Clinician Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanna L Fryer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco Healthcare System

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason Hemmerle, MBA

Role: CONTACT

415 221 4810 ext. 24711

Kaitlyn Dal Bon, BA

Role: CONTACT

415 221 4810 ext. 23946

Facility Contacts

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Jason Hemmerle, MBA

Role: primary

415-221-4810 ext. 24711

Other Identifiers

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CX001980

Identifier Type: -

Identifier Source: org_study_id

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