A Neurobiological Model of Anhedonia

NCT05629520 | Completed

• 2 other identifiers: STUDY00011450UL1TR002014
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand anhedonia in Major Depressive Disorder by investigating the reward-related neural and inflammatory correlates.

Conditions

Anhedonia; Depression

Keywords

Depression; Anhedonia; Reward Related Neural Circuitry; Inflammation

Outcome Measures

Primary Outcomes (4)

• Basal inflammatory marker assessment

  Quantify the profile of basal inflammatory markers (IL-6 and C-reactive protein) in blood. Blood will be collected within an hour after consent and will be processed by 3 hours.

  1 hour

• Behavior during reward-based task - Monetary Incentive Delay Task

  Participants will complete the Monetary Incentive Delay (MID) task, a reward-based task, while undergoing functional magnetic resonance imaging (fMRI). Results will include button press reaction time for the MID task.

  30 minutes

• Behavior during reward-based task - Reward Probabilistic Reversal Learning Task

  Participants will complete a Reward Probabilistic Reversal Learning Task, a reward-based task, while undergoing functional magnetic resonance imaging (fMRI). Results will include choice behavior, either choice A or choice B, (button press) for this task.

  30 minutes

• Blood oxygen level dependent (BOLD) activation during reward-based tasks

  Participants will undergo functional magnetic resonance imaging (fMRI) while completing the tasks in Outcome 2. Ventral striatum activation during the tasks will be measured by % BOLD signal change. The expected signal change is between .1-.8%.

  1 hour

Secondary Outcomes (3)

• Mediation model between inflammation and anhedonia

  3 hours

• Exploratory inflammatory marker assessment

  3 hours

• Exploratory analysis of reward related regions

  3 hours

Other Outcomes (7)

• Punishment-Based Probabilistic Reversal Learning Task Performance

  30 minutes

• Delay Discounting Task Performance

  30 minutes

• Stroop Task

  15 minutes

Study Arms (1)

Participants with Major Depressive Disorder including TRD

Treatment resistant depression (TRD) participants are defined as participants with Major Depressive Disorder (MDD) who fail to respond to at least two lines of antidepressant medication treatment interventions.

Eligibility Criteria

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

Study Population

Participants will be recruited from the surrounding community as well as through clinics associated with a central Pennsylvania medical center.

You may qualify if:

• Current diagnosis of MDD based on the MINI International Neuropsychiatric Interview (MINI)
• For treatment resistant depression participants: unsuccessful treatment with at least 2 types or doses of antidepressant medication treatment
• Right-handed
• Capacity for informed consent
• Score a 9 or higher on the MADRS

You may not qualify if:

• Comorbid Bipolar Disorder
• Substance use disorder in the last 12 months
• Schizophrenia, and other psychotic disorders
• Comorbid illness such as endocrinological illness (e.g. Cushing's disease) rheumatologic illness (e.g., systemic Lupus erythematosus, current treatment with glucocorticoids), and autoimmune diseases (e.g. psoriasis)
• Pregnancy
• Daily NSAID or aspirin use and any metallic implant
• Visual/Hearing Impairments that would keep participant from being able to complete tasks

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma and saliva.

MeSH Terms

Conditions

Anhedonia; Depression; Inflammation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Pathologic Processes

Study Officials

• Dahlia Mukherjee, Ph.D

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Behavioral Health

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 29, 2022
• Study Start: February 19, 2020
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

US (1)