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Principal Investigator left institution.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnenolone 175mg | Active Comparator | - Single dose of 175mg |
|
| Pregnenolone 400mg | Active Comparator | - Single dose of 400mg |
|
| Placebo | Placebo Comparator | - Single dose of placebo |
|
| Matched healthy controls | No Intervention | - No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnenolone 175mg | Drug | Single Dose 175mg |
| |
| Pregnenolone 400mg |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Results | 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). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Eye Movement Tracking | Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Cacioppo, PhD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26365247 | Background | Cacioppo S, Cacioppo JT. Why may allopregnanolone help alleviate loneliness? Med Hypotheses. 2015 Dec;85(6):947-52. doi: 10.1016/j.mehy.2015.09.004. Epub 2015 Sep 5. | |
| 25222636 | Background | Cacioppo S, Capitanio JP, Cacioppo JT. Toward a neurology of loneliness. Psychol Bull. 2014 Nov;140(6):1464-504. doi: 10.1037/a0037618. Epub 2014 Sep 15. |
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No participants started the trial and received the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnenolone 175mg | - Single dose of 175mg Pregnenolone 175mg: Single Dose 175mg |
| FG001 | Pregnenolone 400mg | - Single dose of 400mg Pregnenolone 400mg: Single Dose 400mg |
| FG002 | Placebo | - Single dose of placebo Placebo: Single Dose |
| FG003 | Matched Healthy Controls | - No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No data was collected or analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnenolone 175mg | - Single dose of 175mg Pregnenolone 175mg: Single Dose 175mg |
| BG001 | Pregnenolone 400mg | - Single dose of 400mg Pregnenolone 400mg: Single Dose 400mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | EEG Results | 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). | No data was collected or analyzed due to Principal Investigator leaving the institution. | Posted | 8 weeks |
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnenolone 175mg | - Single dose of 175mg Pregnenolone 175mg: Single Dose 175mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Compliance Specialist | University of Chicago | 773-702-6505 | czwieg@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2019 | May 6, 2024 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2019 | Apr 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011284 | Pregnenolone |
| ID | Term |
|---|---|
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
Single Dose 400mg |
|
| Placebo | Drug | Single Dose |
|
| 18391192 | Background | Pibiri F, Nelson M, Guidotti A, Costa E, Pinna G. Decreased corticolimbic allopregnanolone expression during social isolation enhances contextual fear: A model relevant for posttraumatic stress disorder. Proc Natl Acad Sci U S A. 2008 Apr 8;105(14):5567-72. doi: 10.1073/pnas.0801853105. Epub 2008 Apr 7. |
| 18096321 | Background | Porcu P, O'Buckley TK, Leslie Morrow A, Adinoff B. Differential hypothalamic-pituitary-adrenal activation of the neuroactive steroids pregnenolone sulfate and deoxycorticosterone in healthy controls and alcohol-dependent subjects. Psychoneuroendocrinology. 2008 Feb;33(2):214-26. doi: 10.1016/j.psyneuen.2007.11.003. Epub 2007 Dec 21. |
| 16934764 | Background | Rasmusson AM, Pinna G, Paliwal P, Weisman D, Gottschalk C, Charney D, Krystal J, Guidotti A. Decreased cerebrospinal fluid allopregnanolone levels in women with posttraumatic stress disorder. Biol Psychiatry. 2006 Oct 1;60(7):704-13. doi: 10.1016/j.biopsych.2006.03.026. Epub 2006 Aug 24. |
| 26856852 | Background | Crowley SK, O'Buckley TK, Schiller CE, Stuebe A, Morrow AL, Girdler SS. Blunted neuroactive steroid and HPA axis responses to stress are associated with reduced sleep quality and negative affect in pregnancy: a pilot study. Psychopharmacology (Berl). 2016 Apr;233(7):1299-310. doi: 10.1007/s00213-016-4217-x. Epub 2016 Feb 9. |
| 12916575 | Background | Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348. |
| 19339966 | Background | Marx CE, Keefe RS, Buchanan RW, Hamer RM, Kilts JD, Bradford DW, Strauss JL, Naylor JC, Payne VM, Lieberman JA, Savitz AJ, Leimone LA, Dunn L, Porcu P, Morrow AL, Shampine LJ. Proof-of-concept trial with the neurosteroid pregnenolone targeting cognitive and negative symptoms in schizophrenia. Neuropsychopharmacology. 2009 Jul;34(8):1885-903. doi: 10.1038/npp.2009.26. Epub 2009 Apr 1. |
| 16432684 | Background | Pinna G, Costa E, Guidotti A. Fluoxetine and norfluoxetine stereospecifically and selectively increase brain neurosteroid content at doses that are inactive on 5-HT reuptake. Psychopharmacology (Berl). 2006 Jun;186(3):362-72. doi: 10.1007/s00213-005-0213-2. Epub 2006 Jan 24. |
| 12420152 | Background | van Broekhoven F, Verkes RJ. Neurosteroids in depression: a review. Psychopharmacology (Berl). 2003 Jan;165(2):97-110. doi: 10.1007/s00213-002-1257-1. Epub 2002 Nov 6. |
| BG002 | Placebo | - Single dose of placebo Placebo: Single Dose |
| BG003 | Matched Healthy Controls | - No intervention |
| BG004 | Total | Total of all reporting groups |
|
| Age, Continuous | Participants |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| OG002 | Placebo | - Single dose of placebo Placebo: Single Dose |
| OG003 | Matched Healthy Controls | - No intervention |
|
| Secondary | Eye Movement Tracking | Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks. | No data was collected or analyzed due to Investigator leaving the institution. | Posted | 8 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Pregnenolone 400mg | - Single dose of 400mg Pregnenolone 400mg: Single Dose 400mg | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Placebo | - Single dose of placebo Placebo: Single Dose | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Matched Healthy Controls | - No intervention | 0 | 0 | 0 | 0 | 0 | 0 |
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| D011083 |
| Polycyclic Compounds |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |