Perceived Social Isolation Clinical Trial
Official title:
Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study
| Verified date | May 2024 |
| Source | University of Chicago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 34 |
| Est. completion date | December 21, 2022 |
| Est. primary completion date | December 21, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| University of Chicago |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | 8 weeks | |
| Secondary | Eye Movement Tracking | Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks. | 8 weeks |