Inflammation and Threat Sensitivity in PTSD
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Posttraumatic Stress Disorder
In brief
The overall goals of this study are to examine the relationship between chronic inflammation and threat and reward sensitivity, and to determine the effects of acute inflammation on threat sensitivity, in individuals with and without moderate to severe PTSD symptoms. The investigators will first conduct an observational study to examine the relationship between chronic inflammation and neural and behavioral measures of threat sensitivity. Then, the investigators will conduct a randomized, double-blind, placebo-controlled, between-subjects study to examine the effects of acute inflammation on neural and behavioral measures of threat sensitivity.
Key facts
- Study ID
- NCT03048929
- Run by
- University of California, San Francisco
- People needed
- 30
- Starts
- 2019-04-01
- Expected to finish
- 2021-03-31
- Last updated by the study team
- 2021-05-13
Who can join
Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All Subjects:
- Veterans aged 30-60.
- PTSD Subjects:
- Positive for current chronic moderate to severe PTSD symptoms of at least three months duration as indexed by the Clinically Administered PTSD Scale for DSM 5 (CAPS-5).
- Control Subjects:
- Negative for lifetime PTSD.
- Negative for lifetime diagnosis of Mood Disorders, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder and Panic Disorder.
You may not qualify if…
- All Subjects:
- Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, panic 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.
- Diagnosis of neurologic disorder, systemic illness affecting central nervous system function, and/or anemia.
- Prominent suicidal or homicidal ideation.
- Current and planned ongoing use of medications that impact inflammation or immune function, or use of such medications in the past 6 months.
- Subjects currently receiving serotonin reuptake inhibitors (SSRIs), benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, any antidepressant medication including trazodone.
- 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 Magnetic Resonance Imaging (MRI), which include claustrophobia severe enough to prevent MRI examination and presence of ferrometallic objects in the body that would interfere with MR examination and/or cause a safety risk (e.g., pace makers, implanted stimulators, pumps).
- Contraindications to typhoid vaccine, which include acute febrile illness within the past two weeks, disorders characterized by a deficiency in ability to mount a humoral or cell-mediated immune response, use of anti-malarial medications in past six months, antibiotics in past three months, a history of hypersensitivity to typhoid vaccine or any other vaccine, previous immunization with whole-cell typhoid or live, oral typhoid vaccine, vaccination with the polysaccharide version of the typhoid vaccine within the past 3 year, coagulation disorders and thrombocytopenia.
- Conditions or use of substances that may be associated with inflammation independent of trauma and PTSD, including chronic physical disease.
- History of neurologic disorders, traumatic brain injury (TBI), brain tumor, brain hemorrhage, or head injury with loss of consciousness.
- Women who are currently, or are planning to become, pregnant during the study.
- The investigators will not exclude PTSD patients who are receiving psychotherapy, but will apply the following criteria: patients must have been in treatment for 6 months, meet symptomatic criteria for inclusion, and do not have plans to discontinue treatment during the course of the study.
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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