Cognitive, Emotional, and Neural Responses to Acute Inflammation

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03294564

Run by

University of California, San Francisco

People needed

24

Starts

2018-01-01

Expected to finish

2018-12-30

Last updated by the study team

2019-06-25

Who can join

Age: 30 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy individuals (free of chronic illness or lifetime history of psychiatric disorder)
• Non-smokers

You may not qualify if…

• 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

Where it is running

• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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