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Effects of Pregnenolone on Perceived Social Isolation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02826577
Recruitment Status : Terminated (Principal Investigator left institution.)
First Posted : July 11, 2016
Results First Posted : May 16, 2024
Last Update Posted : May 16, 2024
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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
Actual Primary Completion Date : December 21, 2021
Actual Study Completion Date : December 21, 2022

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.

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02826577

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Stephanie Cacioppo, PhD University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Informed Consent Form  [PDF] July 26, 2019


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Responsible Party: University of Chicago Identifier: NCT02826577    
Other Study ID Numbers: 16-0834
First Posted: July 11, 2016    Key Record Dates
Results First Posted: May 16, 2024
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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