Effects of Pregnenolone on Perceived Social Isolation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2022-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

NCT00728728

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE2

Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia

NCT00560937

Schizophrenia

COMPLETED NA

Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

NCT00894842

Schizophrenia

COMPLETED PHASE2/PHASE3

Efficacy of Pregnenolone in Patients With Schizophrenia

NCT00615511

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE2

Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia

NCT00847600

Schizophrenia Schizophreniform Disorder Schizoaffective Disorders

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perceived Social Isolation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnenolone 175mg

\- Single dose of 175mg

Group Type ACTIVE_COMPARATOR

Pregnenolone 175mg

Intervention Type DRUG

Single Dose 175mg

Pregnenolone 400mg

\- Single dose of 400mg

Group Type ACTIVE_COMPARATOR

Pregnenolone 400mg

Intervention Type DRUG

Single Dose 400mg

Placebo

\- Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single Dose

Matched healthy controls

\- No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregnenolone 175mg

Single Dose 175mg

Intervention Type DRUG

Pregnenolone 400mg

Single Dose 400mg

Intervention Type DRUG

Placebo

Single Dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes