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

NCT01856530 | Completed Phase 1 Results DMC

• 1 other identifier: H-31668
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Perceived Trust Scores on a 1-7 Likert Scale

  Day 1 (first day oxytocin or placebo was administered)

• Perceived Empathy Scores on a 1-7 Likert Scale

  Day 1 (first day oxytocin or placebo was administered)

• Perceived Preference Scores on a 1-7 Likert Scale

  Day 1 (first day oxytocin or placebo was administered)

• Perceived Rejection Scores on a 1-7 Likert Scale

  Day 1 (first day oxytocin or placebo was administered)

Study Arms (2)

Oxytocin

EXPERIMENTAL

Liquid intranasal oxytocin, 24 IU, administered once

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Matched placebo nasal spray

Drug: Placebo

Interventions

Oxytocin DRUG

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

Oxytocin

Placebo DRUG

Matched placebo nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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.

Sponsors & Collaborators

• Stefan G. Hofmann: lead

Study Sites (1)

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 28559206 DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Stefan G. Hofmann
• Organization: Boston University

shofmann@bu.edu

617-353-9233

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 17, 2013
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 13, 2018
• Results First Posted: August 15, 2014

Record last verified: 2018-01

Locations

US (1)