NCT00949845

Brief Summary

Recent research has demonstrated a relationship between depression and immune system activity, specifically proinflammatory cytokine activity. Although experimentally-induced immune activation leads to increases in depressed mood, the neural correlates associated with these changes have remained largely unexplored. Based on relationships between cytokine activity, depression, and heightened physical and social pain sensitivity, I propose to investigate the effect of proinflammatory cytokine activation on the neural correlates of socially painful experience that may contribute to depression. Our previous work has shown that the dorsal anterior cingulate cortex (dACC), typically associated with physical pain distress, also plays a role in the distressing feelings associated with social rejection or social loss. Moreover, recent pilot data has revealed that individuals with elevated levels of baseline proinflammatory cytokines report feeling more distressed and show more dACC activity during social rejection. To investigate the causal role that cytokines may play in the heightened social pain sensitivity that can contribute to depression, participants will be randomly assigned to receive either endotoxin (which increases proinflammatory cytokine activity) or placebo. Subsequently, participants will complete a neuroimaging study in which they will be rejected during an online ball-tossing game. We hypothesize that individuals exposed to endotoxin will report more social distress and depression following rejection and will show more dACC reactivity during rejection. The proposed study is the first to investigate the effect of systemic inflammation on neural reactivity related to social and affective processes that may increase the risk of depression.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

First QC Date

July 29, 2009

Last Update Submit

July 29, 2009

Conditions

Keywords

Effect of Inflammatory challenge on depressed moodEffect of inflammatory challenge on social pain

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed

You may not qualify if:

  • \) BMI greater than 30,
  • \) presence of physical health problems or medication use,
  • \) evidence of an Axis I psychiatric disorder based on the SCID assessment,
  • \) evidence of recreational drug use from a positive urine test,
  • \) positive pregnancy test, if female,
  • \) abnormalities on screening laboratory tests (blood cell count, liver function),
  • \) claustrophobia,
  • \) metal in body,
  • \) history of allergies, autoimmune, liver, or other severe chronic diseases,
  • \) current use of prescription medications,
  • \) nightshift work or time zone shifts (\> 3hrs) within the previous 6 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA General Clinical Research Center

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • Eisenberger NI, Inagaki TK, Rameson LT, Mashal NM, Irwin MR. An fMRI study of cytokine-induced depressed mood and social pain: the role of sex differences. Neuroimage. 2009 Sep;47(3):881-90. doi: 10.1016/j.neuroimage.2009.04.040. Epub 2009 Apr 17.

  • Eisenberger NI, Berkman ET, Inagaki TK, Rameson LT, Mashal NM, Irwin MR. Inflammation-induced anhedonia: endotoxin reduces ventral striatum responses to reward. Biol Psychiatry. 2010 Oct 15;68(8):748-54. doi: 10.1016/j.biopsych.2010.06.010. Epub 2010 Aug 16.

MeSH Terms

Conditions

Depression

Interventions

Endotoxins

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Bacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Naomi I Eisenberger, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Purpose
BASIC SCIENCE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

January 1, 2007

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations