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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Social Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT01856530

Run by

Stefan G. Hofmann

People needed

60

Starts

2012-07-01

Expected to finish

2013-08-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Anxiety and Related Disorders at Boston University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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