Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856530
• Other study ID #: H-31668
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 10, 2013
• Last updated: January 16, 2018
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2018
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Drug:
• Oxytocin
Liquid metered-dose nasal spray, 24 IU, administered once
• Placebo
Matched placebo nasal spray

Locations

Country	Name	City	State
United States	Center for Anxiety and Related Disorders at Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stefan G. Hofmann

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Cooperation	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.	Day 1 (first day oxytocin or placebo was administered)
Primary	Disengagement From Social Threat Cues	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.	Day 1 (first day oxytocin or placebo was administered)
Secondary	Perceived Trust Scores on a 1-7 Likert Scale	Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.	Day 1 (first day oxytocin or placebo was administered)
Secondary	Perceived Empathy Scores on a 1-7 Likert Scale	Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.	Day 1 (first day oxytocin or placebo was administered)
Secondary	Perceived Preference Scores on a 1-7 Likert Scale	Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.	Day 1 (first day oxytocin or placebo was administered)
Secondary	Perceived Rejection Scores on a 1-7 Likert Scale	Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.	Day 1 (first day oxytocin or placebo was administered)