Clinical trial NCT01856530: Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
Official title: Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Social Anxiety Disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Social Cooperation
timeFrame: Day 1 (first day oxytocin or placebo was administered)
measure: Disengagement From Social Threat Cues
timeFrame: Day 1 (first day oxytocin or placebo was administered)
Secondary outcomes:
measure: Perceived Trust Scores on a 1-7 Likert Scale
timeFrame: Day 1 (first day oxytocin or placebo was administered)
measure: Perceived Empathy Scores on a 1-7 Likert Scale
timeFrame: Day 1 (first day oxytocin or placebo was administered)
measure: Perceived Preference Scores on a 1-7 Likert Scale
timeFrame: Day 1 (first day oxytocin or placebo was administered)
measure: Perceived Rejection Scores on a 1-7 Likert Scale
timeFrame: Day 1 (first day oxytocin or placebo was administered)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Related Disorders at Boston University
state: Massachusetts
Study officials:
References:
citation: Fang A, Treadway MT, Hofmann SG. Working hard for oneself or others: Effects of oxytocin on reward motivation in social anxiety disorder. Biol Psychol. 2017 Jul;127:157-162. doi: 10.1016/j.biopsycho.2017.05.015. Epub 2017 May 27.