Clinical trial NCT05629520: A Neurobiological Model of Anhedonia
Official title: Inflammatory, Behavioral and Neural Markers of Anhedonia in Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anhedonia
Depression
Keywords: Depression
Anhedonia
Reward Related Neural Circuitry
Inflammation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Background: Despite extensive research on the treatment of Major Depressive Disorder (MDD) relapse rates are as high as 80%. Of those, 30-40% fall into the severe spectrum called treatment resistant depression (TRD) as they fail to respond to at least two lines of antidepressant treatment interventions. TRD has been linked with anhedonia, the inability to experience pleasure or interest in usually enjoyable activities. The neurobiology of anhedonia is poorly understood with recent literature examining an inflammatory association and linking it to deficits in reward-related brain circuitry. The present study examines neurobiological correlates of anhedonia in MDD and TRD, specifically C-Reactive Protein (CRP), IL-6 and ventral striatal (VS) activity. The study also explores whether VS activity mediates the association between inflammation and anhedonia.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Basal inflammatory marker assessment
timeFrame: 1 hour
measure: Behavior during reward-based task - Monetary Incentive Delay Task
timeFrame: 30 minutes
measure: Behavior during reward-based task - Reward Probabilistic Reversal Learning Task
timeFrame: 30 minutes
measure: Blood oxygen level dependent (BOLD) activation during reward-based tasks
timeFrame: 1 hour
Secondary outcomes:
measure: Mediation model between inflammation and anhedonia
timeFrame: 3 hours
measure: Exploratory inflammatory marker assessment
timeFrame: 3 hours
measure: Exploratory analysis of reward related regions
timeFrame: 3 hours
Other outcomes:
measure: Punishment-Based Probabilistic Reversal Learning Task Performance
timeFrame: 30 minutes
measure: Delay Discounting Task Performance
timeFrame: 30 minutes
measure: Stroop Task
timeFrame: 15 minutes
measure: Go/No-Go Task
timeFrame: 5 minutes
measure: Wisconsin Card Sorting Task
timeFrame: 20 minutes
measure: N-Back Task
timeFrame: 20 minutes
measure: Lexical Decision Task
timeFrame: 5 minutes
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Dahlia Mukherjee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: