A Phase 2 interventional study of Pregnenolone 175mg and Pregnenolone 400mg in Perceived Social Isolation, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Chicago · Phase 2, Interventional, and Basic science
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.
University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
\- Single dose of 175mg
Drug: Pregnenolone 175mg
\- Single dose of 400mg
Drug: Pregnenolone 400mg
\- Single dose of placebo
Drug: Placebo
\- No intervention
Single Dose 175mg
Single Dose 400mg
Single Dose
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
Eye Movement Tracking
Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.
Time frame: 8 weeks
| Milestone | Pregnenolone 175mg | Pregnenolone 400mg | Placebo | Matched Healthy Controls |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
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).
No measurements were reported for this outcome.
Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.
No measurements were reported for this outcome.
Collected over All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregnenolone 175mg | — | — | — |
| Pregnenolone 400mg | — | — | — |
| Placebo | — | — | — |
| Matched Healthy Controls | — | — | — |
No data was collected or analyzed
| Age, Categorical | Pregnenolone 175mg | Pregnenolone 400mg | Placebo | Matched Healthy Controls | Total |
|---|---|---|---|---|---|
| <=18 years | — | — | — | — | — |
| Between 18 and 65 years | — | — | — | — | — |
| >=65 years | — | — | — | — | — |
| Age, Continuous(Participants) | Pregnenolone 175mg | Pregnenolone 400mg | Placebo | Matched Healthy Controls | Total |
|---|
| Sex: Female, Male | Pregnenolone 175mg | Pregnenolone 400mg | Placebo | Matched Healthy Controls | Total |
|---|---|---|---|---|---|
| Female | — | — | — | — | — |
| Male | — | — | — | — | — |
| Race (NIH/OMB) | Pregnenolone 175mg | Pregnenolone 400mg | Placebo | Matched Healthy Controls | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | — | — | — | — | — |
| Asian | — | — | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — | — | — |
| Black or African American | — | — | — | — | — |
| White | — | — | — | — | — |
| More than one race | — | — | — | — | — |
| Unknown or Not Reported | — | — | — | — | — |
| Region of Enrollment(participants) | Pregnenolone 175mg | Pregnenolone 400mg | Placebo | Matched Healthy Controls | Total |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pregnenolone