Effects of Pregnenolone on Perceived Social Isolation

Phase 2

Terminated

• Conditions: Perceived Social Isolation
• Interventions: Drug: Pregnenolone 175mg; Drug: Placebo; Drug: Pregnenolone 400mg

• Registration Number: NCT02826577
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Study Start: 2017-05-01
• Primary Completion: 2021-12-21
• Study Completion: 2022-12-21
• Results First Submitted: 2023-04-13
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Results First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Age 21-80
• At least a score of 42 on the UCLA Loneliness scale.
• Right handed
• Normal or corrected eye sight

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregnenolone 175mg	Pregnenolone 175mg	- Single dose of 175mg
Placebo	Placebo	- Single dose of placebo
Pregnenolone 400mg	Pregnenolone 400mg	- Single dose of 400mg

Primary Outcome Measures

Name	Time	Method
EEG Results	8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Eye Movement Tracking	8 weeks	Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States