NCT02826577

Effects of Pregnenolone on Perceived Social Isolation

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perceived Social Isolation

Interventions

Type	Name	Description
DRUG	Pregnenolone 175mg	Single Dose 175mg
DRUG	Pregnenolone 400mg	Single Dose 400mg
DRUG	Placebo	Single Dose

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-12-21
• Completion: 2022-12-21
• First posted: 2016-07-11
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study