Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Social Cooperation
研究概览
简要总结
The purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. Based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called Cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males > 18 years of age with a primary (or co-principal) psychiatric diagnosis of social anxiety disorder (SAD), as defined by Diagnostic and Statistical Manual-IV (DSM-IV) criteria;
- •Current Liebowitz Social Anxiety Scale (LSAS) score > 60, which is a clinical threshold for SAD symptoms;
- •Comorbid present DSM-IV Major Depression, Dysthymia, Specific Phobia, or any of the other anxiety disorders as diagnosed by DSM-IV criteria will be permitted as long as SAD is primary (the disorder that is most distressing to the patient). Inclusion of patients with comorbidity will permit accrual of a more clinically relevant patient population;
- •Willingness to participate in and comply with the study procedures as indicated by signing the informed consent form.
排除标准
- •Subjects with a serious medical illness for which hospitalization may be likely within the next three months;
- •Subjects with a current diagnosis of schizophrenia, psychotic disorders, bipolar disorder, mental disorder due to a medical condition or substance, substance abuse or dependence, as diagnosed by DSM-IV criteria;
- •Concurrent use of other psychotropic medications is excluded, except for antidepressants that have been taken at a stable dose for at least 2 weeks;
- •Active suicidal or homicidal ideation or suicide attempts within the past six months requiring hospitalization;
- •Subjects with significant nasal pathology (atrophic rhinitis, recurrent nose bleeds, or history of hypophysectomy);
- •Smokers who smoke more than 15 cigarettes per day;
- •Those who smoke cigarettes or have caffeine or alcohol within 24 hours of the study visit.
研究组 & 干预措施
Oxytocin
Liquid intranasal oxytocin, 24 IU, administered once
干预措施: Oxytocin (Drug)
Placebo
Matched placebo nasal spray
干预措施: Placebo (Drug)
结局指标
主要结局
Social Cooperation
时间窗: Day 1 (first day oxytocin or placebo was administered)
The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as "Player 2") played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1.
Disengagement From Social Threat Cues
时间窗: Day 1 (first day oxytocin or placebo was administered)
The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement.
次要结局
- Perceived Trust Scores on a 1-7 Likert Scale(Day 1 (first day oxytocin or placebo was administered))
- Perceived Empathy Scores on a 1-7 Likert Scale(Day 1 (first day oxytocin or placebo was administered))
- Perceived Preference Scores on a 1-7 Likert Scale(Day 1 (first day oxytocin or placebo was administered))
- Perceived Rejection Scores on a 1-7 Likert Scale(Day 1 (first day oxytocin or placebo was administered))
研究者
Stefan G. Hofmann
Principal Investigator
Boston University Charles River Campus