Perceived Social Isolation
Conditions
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.
Interventions
DRUGPregnenolone 175mg
Single Dose 175mg
DRUGPregnenolone 400mg
Single Dose 400mg
DRUGPlacebo
Single Dose
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Eye Movement Tracking | 8 weeks | Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks. |
Countries
United States
Participant flow
Pre-assignment details
No participants started the trial and received the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Pregnenolone 175mg \- Single dose of 175mg
Pregnenolone 175mg: Single Dose 175mg | 0 |
| Pregnenolone 400mg \- Single dose of 400mg
Pregnenolone 400mg: Single Dose 400mg | 0 |
| Placebo \- Single dose of placebo
Placebo: Single Dose | 0 |
| Matched Healthy Controls \- No intervention | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: No data was collected or analyzed due to Principal Investigator leaving the institution.
Secondary
Eye Movement Tracking
Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.
Time frame: 8 weeks
Population: No data was collected or analyzed due to Investigator leaving the institution.