Cytokine-Associated Depression and Social Pain

July 29, 2009 updated by: University of California, Los Angeles

An fMRI Study of Cytokine-Associated Depression and Social Pain

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.

Study Overview

Status

Status

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Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA General Clinical Research Center

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • right-handed

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science

Collaborators and Investigators

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Sponsor

Sponsor

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University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Naomi I Eisenberger, Ph.D., University of California, Los Angeles

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

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January 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Endotoxin

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