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Effects of Pregnenolone on Perceived Social Isolation

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ClinicalTrials.gov Identifier: NCT02826577
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Perceived Social Isolation Drug: Pregnenolone 175mg Drug: Pregnenolone 400mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pregnenolone 175mg
- Single dose of 175mg
Drug: Pregnenolone 175mg
Single Dose 175mg

Active Comparator: Pregnenolone 400mg
- Single dose of 400mg
Drug: Pregnenolone 400mg
Single Dose 400mg

Placebo Comparator: Placebo
- Single dose of placebo
Drug: Placebo
Single Dose

No Intervention: Matched healthy controls
- No intervention



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Eye movement tracking [ Time Frame: 8 weeks ]
    Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826577


Contacts
Contact: Erika Kaske 773-834-5264 ekaske@yoda.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Erika Kaske    773-834-5264    ekaske@yoda.bsd.uchicago.edu   
Contact: Stephanie Cacioppo, PhD    773-702-6983    scacioppo@yoda.bsd.uchicago.edu   
Principal Investigator: Stephanie Cacioppo, PhD         
Sub-Investigator: Jon E Grant, JD, MD, MPH         
Sub-Investigator: Royce Lee, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Stephanie Cacioppo, PhD University of Chicago

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02826577     History of Changes
Other Study ID Numbers: 16-0834
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No