Status:
COMPLETED
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
Lead Sponsor:
Stefan G. Hofmann
Conditions:
Social Anxiety Disorder
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01856530
Start Date
July 1 2012
End Date
August 1 2013
Last Update
February 13 2018
Active Locations (1)
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1
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, United States, 02215