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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00949845
Other study ID # Endotoxin
Secondary ID
Status Completed
Phase Phase 0
First received July 29, 2009
Last updated July 29, 2009
Start date January 2007

Study information

Verified date July 2009
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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 Design

Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Endotoxin


Locations

Country Name City State
United States UCLA General Clinical Research Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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