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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856530
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : August 15, 2014
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Stefan G. Hofmann, Boston University Charles River Campus

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Oxytocin Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder
Study Start Date : July 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Liquid intranasal oxytocin, 24 IU, administered once
Drug: Oxytocin
Liquid metered-dose nasal spray, 24 IU, administered once

Placebo Comparator: Placebo
Matched placebo nasal spray
Drug: Placebo
Matched placebo nasal spray




Primary Outcome Measures :
  1. Social Cooperation [ Time Frame: Day 1 (first day oxytocin or placebo was administered) ]
    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.

  2. Disengagement From Social Threat Cues [ Time Frame: Day 1 (first day oxytocin or placebo was administered) ]
    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.


Secondary Outcome Measures :
  1. Perceived Trust Scores on a 1-7 Likert Scale [ Time Frame: Day 1 (first day oxytocin or placebo was administered) ]
    Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.

  2. Perceived Empathy Scores on a 1-7 Likert Scale [ Time Frame: Day 1 (first day oxytocin or placebo was administered) ]
    Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.

  3. Perceived Preference Scores on a 1-7 Likert Scale [ Time Frame: Day 1 (first day oxytocin or placebo was administered) ]
    Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.

  4. Perceived Rejection Scores on a 1-7 Likert Scale [ Time Frame: Day 1 (first day oxytocin or placebo was administered) ]
    Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856530


Locations
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United States, Massachusetts
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Stefan G. Hofmann
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefan G. Hofmann, Principal Investigator, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT01856530    
Other Study ID Numbers: H-31668
First Posted: May 17, 2013    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: February 13, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs