Status:
COMPLETED
Cognitive, Emotional, and Neural Responses to Acute Inflammation
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Healthy
Eligibility:
MALE
30-60 years
Phase:
EARLY_PHASE1
Brief Summary
This study is a pilot study to examine the effects of acute inflammation on cognition and emotion in healthy participants using a between-subjects, randomized, double-blind design.
Detailed Description
The inflammatory response of the immune system is responsive to stress and it impacts brain function. Animal studies have shown that inflammation appears to alter threat- and reward-related brain acti...
Eligibility Criteria
Inclusion
- Healthy individuals (free of chronic illness or lifetime history of psychiatric disorder)
- Non-smokers
Exclusion
- Lifetime history of an psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder, alcohol or substance dependence, or a history of alcohol or substance abuse within the past 2 years.
- Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months, or has current diagnosis of PTSD.
- Diagnosis of sleep apnea, neurological disorder, systemic illness affective central nervous system function, and/or anemia.
- Any suicidal or homicidal ideation within the past year.
- Subjects currently receiving selective serotonin reuptake inhibitors (SSRIs), benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, any antidepressant medication including trazodone, or any psychotropic medication.
- Termination of SSRIs, benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, any antidepressant medication including trazodone in the last month, or plans to start these medications during the course of the study.
- Contraindications to fMRI, including severe claustrophobia and presence of ferromagnetic objects in the body that would interfere with magnetic resonance examination and/or cause a safety risk (e.g., pace makers, implanted stimulators, pumps, extensive dental work, upper body tattoos).
- Contraindications to typhoid vaccine, which include acute febrile illness within the past two weeks, disorders characterized by a deficiency to ability to mount a humoral or cell-mediated immune response, use of anti-malarial medications in the past six months, antibiotics in past three months, a history of hypersensitivity to typhoid vaccine or any other vaccine, pervious immunization with whole-cell typhoid or live, oral typhoid vaccines, vaccination with the polysaccharide version of the typhoid vaccine within the past 3 years.
- Conditions or use of substances that may be associated with inflammation, including drugs that affect the immune system.
- Any chronic medical illness.
- Having a body mass index (BMI) over 30.
- Individuals who work the night shift
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03294564
Start Date
January 1 2018
End Date
December 30 2018
Last Update
June 25 2019
Active Locations (2)
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1
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
2
University of California, San Francisco
San Francisco, California, United States, 94143