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NCT02826577 · ClinicalTrials.gov registry record · Phase 2

Effects of Pregnenolone on Perceived Social Isolation

A Phase 2 study, sponsored by University of Chicago.

Terminated
Registry status
Phase 2
Development phase
34
Enrollment target

NCT02826577: Clinical Trial Phase 2 study, sponsored by University of Chicago.

NCT02826577 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02826577, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.

TERMINATED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • DRUG Placebo
  • DRUG Pregnenolone 175mg
  • DRUG Pregnenolone 400mg

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-05-01
Est. Completion 2022-12-21
Phase Phase 2
University of Chicago

796 total trials

Why NCT02826577 stopped before completion

NCT02826577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02826577 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02826577 about?

NCT02826577 is a clinical study titled "Effects of Pregnenolone on Perceived Social Isolation". 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, perce...

What is the current status of trial NCT02826577?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-05-01. Estimated completion is 2022-12-21.

What interventions are being tested in trial NCT02826577?

The interventions under investigation include: Placebo (DRUG), Pregnenolone 175mg (DRUG), Pregnenolone 400mg (DRUG).

Who is sponsoring clinical trial NCT02826577?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02826577's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02826577, the US trial registry maintained by the National Library of Medicine. NCT02826577 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.