- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949845
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
Study Type
Interventional
Phase
- 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
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California
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Los Angeles, California, United States, 90095
- UCLA General Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
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
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Naomi I Eisenberger, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Registration Dates
First Submitted
July 29, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Estimate)
July 30, 2009
Last Update Submitted That Met QC Criteria
July 29, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endotoxin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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