- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826577
Effects of Pregnenolone on Perceived Social Isolation
January 15, 2021 updated by: University of Chicago
Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pregnenolone 175mg
- Single dose of 175mg
|
Single Dose 175mg
|
Active Comparator: Pregnenolone 400mg
- Single dose of 400mg
|
Single Dose 400mg
|
Placebo Comparator: Placebo
- Single dose of placebo
|
Single Dose
|
No Intervention: Matched healthy controls
- No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eye movement tracking
Time Frame: 8 weeks
|
Movements to first saccades.
Change from baseline eye movement tracking results at 8 weeks.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephanie Cacioppo, PhD, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
December 21, 2021
Study Completion (Anticipated)
December 21, 2022
Study Registration Dates
First Submitted
July 1, 2016
First Submitted That Met QC Criteria
July 5, 2016
First Posted (Estimate)
July 11, 2016
Study Record Updates
Last Update Posted (Actual)
January 19, 2021
Last Update Submitted That Met QC Criteria
January 15, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 16-0834
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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