Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event)
研究概览
简要总结
The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual desire as a manipulation check. The investigators will address this goal using a double-blind randomized outpatient design and determine the pre-post neurobehavioral change in the Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity in premenopausal women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior (as measured with self-report measures of sexual desire and/or eye-tracking movements).
详细描述
Hypoactive sexual desire disorder (HSDD) is the most common sexual complaint in women. Over the past 8 years, Dr. Stephanie Cacioppo has developed and validated the Desire Intention task, in which individuals are instructed to indicate as rapidly and as accurately as possible whether or not each visually presented stimulus (e.g., attractive persons of the opposite sex) is sexually desirable to them at the moment of the experiment. Flibanserin (Addyi) is a new medication approved by the FDA for the treatment of HSDD in pre-menopausal women. The investigators propose a study using the DIT to determine the extent to which Flibanserin normalizes brain activity in women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior.
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages 21-45 or 51-74
- •Pre- or Postmenopausal
- •DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD)
- •Right-handed
排除标准
- •Pregnant women
- •Nursing women
- •Post-menopausal women
- •Women who report not being able to stop drinking alcohol during the duration of the study
- •Currently taking psychotropic medication
- •History of seizures or neurological disorders
- •Under hormonal therapy
- •Current or past diagnosis of cancer
- •Any unstable medical illnesses
- •Lifetime history of bipolar disorder, schizophrenia, or psychotic disorder
- •Current or recent (past 3 months) substance abuse or dependence
- •Current or recent (past 3 months) clinical depression
- •Currently taking any medications that have/may have unfavorable interactions with Flibanserin
研究组 & 干预措施
Flibanserin
Drug: Flibanserin
- 8 weeks
- 100mg once daily at bedtime
干预措施: Flibanserin (Drug)
Placebo
Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)
干预措施: Placebo (Drug)
结局指标
主要结局
EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event)
时间窗: 8 weeks
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: Movements to First Saccades(8 weeks)