Effects of Pregnenolone on Perceived Social Isolation: A Double-blind Randomized Electrical Neuroimaging Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- EEG Results
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-80
- •At least a score of 42 on the UCLA Loneliness scale.
- •Right handed
- •Normal or corrected eye sight
排除标准
- •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
研究组 & 干预措施
Pregnenolone 175mg
- Single dose of 175mg
干预措施: Pregnenolone 175mg (Drug)
Pregnenolone 400mg
- Single dose of 400mg
干预措施: Pregnenolone 400mg (Drug)
Placebo
- Single dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
EEG Results
时间窗: 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).
次要结局
- Eye Movement Tracking(8 weeks)