Effects of Pregnenolone on Perceived Social Isolation

Study Overview
=================
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.

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

Conditions
-----------------
Perceived Social Isolation

Intervention / Treatment
-----------------
* Drug: Pregnenolone 175mg
* Drug: Pregnenolone 400mg
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregnenolone 175mg<br>- Single dose of 175mg | Drug: Pregnenolone 175mg<br>* Single Dose 175mg<br>|
| Active Comparator: Pregnenolone 400mg<br>- Single dose of 400mg | Drug: Pregnenolone 400mg<br>* Single Dose 400mg<br>|
| Placebo Comparator: Placebo<br>- Single dose of placebo | Drug: Placebo<br>* Single Dose<br>|
| No Intervention: Matched healthy controls<br>- No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG Results | 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye movement tracking | Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks. | 8 weeks |