Back to resultsEffect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Social Anxiety Disorder
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.
Sites / Locations
- Center for Anxiety and Related Disorders at Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Placebo
Arm Description
Liquid intranasal oxytocin, 24 IU, administered once
Matched placebo nasal spray
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Perceived Trust Scores on a 1-7 Likert Scale
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.
Perceived Empathy Scores on a 1-7 Likert Scale
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.
Perceived Preference Scores on a 1-7 Likert Scale
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.
Perceived Rejection Scores on a 1-7 Likert Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01856530
Brief Title
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
Official Title
Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stefan G. Hofmann
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Liquid intranasal oxytocin, 24 IU, administered once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo nasal spray
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Liquid metered-dose nasal spray, 24 IU, administered once
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo nasal spray
Primary Outcome Measure Information:
Title
Social Cooperation
Description
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.
Time Frame
Day 1 (first day oxytocin or placebo was administered)
Title
Disengagement From Social Threat Cues
Description
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.
Time Frame
Day 1 (first day oxytocin or placebo was administered)
Secondary Outcome Measure Information:
Title
Perceived Trust Scores on a 1-7 Likert Scale
Description
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.
Time Frame
Day 1 (first day oxytocin or placebo was administered)
Title
Perceived Empathy Scores on a 1-7 Likert Scale
Description
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.
Time Frame
Day 1 (first day oxytocin or placebo was administered)
Title
Perceived Preference Scores on a 1-7 Likert Scale
Description
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.
Time Frame
Day 1 (first day oxytocin or placebo was administered)
Title
Perceived Rejection Scores on a 1-7 Likert Scale
Description
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.
Time Frame
Day 1 (first day oxytocin or placebo was administered)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Center for Anxiety and Related Disorders at Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28559206
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
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