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

NCT ID: NCT01856530

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-08-31

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

Liquid intranasal oxytocin, 24 IU, administered once

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Liquid metered-dose nasal spray, 24 IU, administered once

Placebo

Matched placebo nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo nasal spray

Interventions

Oxytocin

Liquid metered-dose nasal spray, 24 IU, administered once

Intervention Type: DRUG

Placebo

Matched placebo nasal spray

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Stefan G. Hofmann

OTHER

Sponsor Role: lead

Responsible Party

Stefan G. Hofmann

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28559206 (View on PubMed)

Other Identifiers

H-31668

Identifier Type: -

Identifier Source: org_study_id