Clinical trial NCT02826577: Effects of Pregnenolone on Perceived Social Isolation
Official title: Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Perceived Social Isolation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: No studies to date have examined the effects of pregnenolone on hypervigilance for social threat in individuals with perceived social isolation (PSI). We therefore are conducting a double-blind randomized research study combining three validated behavioral paradigms on social threat attention, perception of others, and emotion regulation with high-density electrical neuroimaging to probe the neuro-circuitry of social threat processing in young adults high in perceived social isolation two hours after the oral administration of 175mg pregnenolone (N = 24), 400mg of pregnenolone (N = 24), or placebo (N = 24). Such research has the potential to yield important insights into the neurobehavioral mechanisms of pregnenolone on hypervigilance for social threat and perception of others--- a first key step toward the development of adjunctive pregnenolone therapy in individuals with PSI.


Eligibility criteria: Inclusion Criteria:

* Age 21-80
* At least a score of 42 on the UCLA Loneliness scale.
* Right handed
* Normal or corrected eye sight

Exclusion Criteria:

* Medical history of cancer
* Steroid use
* Psychotropic drugs
* History of heart irregularities
* Have a counter indication to EEG
* Age \<21 or \>32
* Score less than 42 on UCLA loneliness scale
* Left handed
* Meet MINI criteria for anything but untreated major depressive disorder
* Uncorrected vision
* Current or past neurological disorder including epilepsy or traumatic brain injury
* Have a counter indication to electrical neuroimaging
* Under hormonal therapy (including, but not limited to, testosterone)
* Unstable mental illness
* History of bipolar disorder, schizophrenia, or psychotic disorder
* Current or recent (past 3 months) substance use or dependence
* Currently taking any medications that may have unfavorable interactions with pregnenolone

Primary outcomes:
measure: EEG Results
timeFrame: 8 weeks
Secondary outcomes:
measure: Eye Movement Tracking
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Stephanie Cacioppo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cacioppo S, Capitanio JP, Cacioppo JT. Toward a neurology of loneliness. Psychol Bull. 2014 Nov;140(6):1464-504. doi: 10.1037/a0037618. Epub 2014 Sep 15.
citation: Pibiri F, Nelson M, Guidotti A, Costa E, Pinna G. Decreased corticolimbic allopregnanolone expression during social isolation enhances contextual fear: A model relevant for posttraumatic stress disorder. Proc Natl Acad Sci U S A. 2008 Apr 8;105(14):5567-72. doi: 10.1073/pnas.0801853105. Epub 2008 Apr 7.
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citation: Rasmusson AM, Pinna G, Paliwal P, Weisman D, Gottschalk C, Charney D, Krystal J, Guidotti A. Decreased cerebrospinal fluid allopregnanolone levels in women with posttraumatic stress disorder. Biol Psychiatry. 2006 Oct 1;60(7):704-13. doi: 10.1016/j.biopsych.2006.03.026. Epub 2006 Aug 24.
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