Effects of Pregnenolone on Perceived Social Isolation

Overview

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.

Full Title of Study: “Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 21, 2021

Interventions

  • Drug: Pregnenolone 175mg
    • Single Dose 175mg
  • Drug: Pregnenolone 400mg
    • Single Dose 400mg
  • Drug: Placebo
    • Single Dose

Arms, Groups and Cohorts

  • Active Comparator: Pregnenolone 175mg
    • – Single dose of 175mg
  • Active Comparator: Pregnenolone 400mg
    • – Single dose of 400mg
  • Placebo Comparator: Placebo
    • – Single dose of placebo
  • No Intervention: Matched healthy controls
    • – No intervention

Clinical Trial Outcome Measures

Primary Measures

  • EEG Results
    • Time Frame: 8 weeks
    • Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event). Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).

Secondary Measures

  • Eye movement tracking
    • Time Frame: 8 weeks
    • Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephanie Cacioppo, PhD, Principal Investigator, University of Chicago

References

Cacioppo S, Cacioppo JT. Why may allopregnanolone help alleviate loneliness? Med Hypotheses. 2015 Dec;85(6):947-52. doi: 10.1016/j.mehy.2015.09.004. Epub 2015 Sep 5.

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.

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.

Porcu P, O'Buckley TK, Leslie Morrow A, Adinoff B. Differential hypothalamic-pituitary-adrenal activation of the neuroactive steroids pregnenolone sulfate and deoxycorticosterone in healthy controls and alcohol-dependent subjects. Psychoneuroendocrinology. 2008 Feb;33(2):214-26. doi: 10.1016/j.psyneuen.2007.11.003. Epub 2007 Dec 21.

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.

Crowley SK, O'Buckley TK, Schiller CE, Stuebe A, Morrow AL, Girdler SS. Blunted neuroactive steroid and HPA axis responses to stress are associated with reduced sleep quality and negative affect in pregnancy: a pilot study. Psychopharmacology (Berl). 2016 Apr;233(7):1299-310. doi: 10.1007/s00213-016-4217-x. Epub 2016 Feb 9.

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

Marx CE, Keefe RS, Buchanan RW, Hamer RM, Kilts JD, Bradford DW, Strauss JL, Naylor JC, Payne VM, Lieberman JA, Savitz AJ, Leimone LA, Dunn L, Porcu P, Morrow AL, Shampine LJ. Proof-of-concept trial with the neurosteroid pregnenolone targeting cognitive and negative symptoms in schizophrenia. Neuropsychopharmacology. 2009 Jul;34(8):1885-903. doi: 10.1038/npp.2009.26. Epub 2009 Apr 1.

Pinna G, Costa E, Guidotti A. Fluoxetine and norfluoxetine stereospecifically and selectively increase brain neurosteroid content at doses that are inactive on 5-HT reuptake. Psychopharmacology (Berl). 2006 Jun;186(3):362-72. doi: 10.1007/s00213-005-0213-2. Epub 2006 Jan 24.

van Broekhoven F, Verkes RJ. Neurosteroids in depression: a review. Psychopharmacology (Berl). 2003 Jan;165(2):97-110. doi: 10.1007/s00213-002-1257-1. Epub 2002 Nov 6.

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