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

16-0834

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.

2017-05-01

2021-12-21

2022-12-21

Terminated

Early phase I

34

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2024-05-16