Effects of Pregnenolone on Perceived Social Isolation

Sponsor

University of Chicago (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02826577

Collaborator

(none)

Enrollment

Location

Arms

67.7

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Dec 21, 2021

Anticipated Study Completion Date :

Dec 21, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

EEG Results [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

Eye movement tracking [8 weeks]
Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Stephanie Cacioppo, PhD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT02826577

Other Study ID Numbers:

16-0834

First Posted:

Jul 11, 2016

Last Update Posted:

Jan 19, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 19, 2021