Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vaginal pulse amplitude via vaginal photoplethysmography
研究概览
简要总结
Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the present pilot study is to examine whether the acute administration of 300mg of caffeine increases genital arousal in women experiencing antidepressant-induced genital arousal difficulties. Women will attend two counterbalanced sessions in which they ingest either 300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film while their heart rate and genital sexual arousal are measured. Caffeine could serve as a low-cost, widely accessible intervention with minimal side effects if efficacy is shown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the of ages 18-55
- •Fluent in English
- •Experience antidepressant-induced arousal difficulties
- •Experience regular menstrual periods (i.e., not perimenopausal or menopausal)
排除标准
- •A history or current diagnosis of panic attacks or panic disorder
- •A history or current diagnosis of sexually transmitted disease(s)
- •A history of major pelvic surgery that caused nerve damage
- •Currently taking beta blockers, antipsychotics, anti-anxiolytics, hormonal contraceptives (unless the participant has been taking it for over 3 months), or any other medical treatment to enhance sexual response
- •Other medical conditions or procedures that would preclude the participant's participation in the study (e.g., urinary tract infection, neurological impairment due to diabetes or stroke, or spinal cord damage)
- •A history of childhood sexual abuse (CSA) that occurred prior to age 16
研究组 & 干预措施
Caffeine
During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules.
干预措施: Caffeine (Drug)
Placebo
During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules.
干预措施: Placebo (Other)
结局指标
主要结局
Vaginal pulse amplitude via vaginal photoplethysmography
时间窗: 15 minutes post-ingestion of caffeine and placebo
Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow
次要结局
- Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale(30 minutes post-ingestion of caffeine and placebo)