Effects of Pregnenolone on Perceived Social Isolation
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| ClinicalTrials.gov Identifier: NCT02826577 |
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Recruitment Status :
Active, not recruiting
First Posted : July 11, 2016
Last Update Posted : January 19, 2021
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Sponsor:
University of Chicago
Information provided by (Responsible Party):
University of Chicago
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perceived Social Isolation | Drug: Pregnenolone 175mg Drug: Pregnenolone 400mg Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 96 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Basic Science |
| Official Title: | Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study |
| Actual Study Start Date : | May 1, 2017 |
| Estimated Primary Completion Date : | December 21, 2021 |
| Estimated Study Completion Date : | December 21, 2022 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Pregnenolone
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Pregnenolone 175mg
- Single dose of 175mg
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Drug: Pregnenolone 175mg
Single Dose 175mg |
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Active Comparator: Pregnenolone 400mg
- Single dose of 400mg
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Drug: Pregnenolone 400mg
Single Dose 400mg |
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Placebo Comparator: Placebo
- Single dose of placebo
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Drug: Placebo
Single Dose |
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No Intervention: Matched healthy controls
- No intervention
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Primary Outcome Measures :
- EEG Results [ Time Frame: 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 :
- Eye movement tracking [ Time Frame: 8 weeks ]Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826577
Locations
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | Stephanie Cacioppo, PhD | University of Chicago |
Publications:
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT02826577 |
| Other Study ID Numbers: |
16-0834 |
| First Posted: | July 11, 2016 Key Record Dates |
| Last Update Posted: | January 19, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |