Effects of Pregnenolone on Perceived Social Isolation

Phase 2TerminatedNCT02826577

University of Chicago34 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Perceived Social Isolation

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 8 weeks

Secondary Outcomes

Eye Movement Tracking

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