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Effects of Pregnenolone on Perceived Social Isolation

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The University of Chicago

Status and phase

Terminated
Phase 2

Conditions

Perceived Social Isolation

Treatments

Drug: Pregnenolone 175mg
Drug: Placebo
Drug: Pregnenolone 400mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02826577
16-0834

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

21 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 4 patient groups, including a placebo group

Pregnenolone 175mg
Active Comparator group
Description:
- Single dose of 175mg
Treatment:
Drug: Pregnenolone 175mg
Pregnenolone 400mg
Active Comparator group
Description:
- Single dose of 400mg
Treatment:
Drug: Pregnenolone 400mg
Placebo
Placebo Comparator group
Description:
- Single dose of placebo
Treatment:
Drug: Placebo
Matched healthy controls
No Intervention group
Description:
- No intervention

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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