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

Stefan G. Hofmann

Status and phase

Completed

Phase 2

Phase 1

Conditions

Social Anxiety Disorder

Treatments

Drug: Oxytocin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01856530

H-31668

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.