Effects of Pregnenolone on Perceived Social Isolation

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

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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