Social Anxiety DisorderPhase 1/2NCT01856530

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

A Phase 1/2 study testing Oxytocin in people with Social Anxiety Disorder, run by Stefan G. Hofmann at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Social Anxiety Disorder
What is being tested?: Oxytocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Aug 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder

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
Being tested: Oxytocin, Placebo
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Liquid metered-dose nasal spray, 24 IU, administered once
PlaceboDrug
Matched placebo nasal spray

Study groups in NCT01856530
Study group	Role	What they receive
Oxytocin	Experimental	Liquid intranasal oxytocin, 24 IU, administered once Receives: Drug: Oxytocin
Placebo	Placebo comparator	Matched placebo nasal spray Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 1 (first day oxytocin or placebo was administered)

Secondary outcomes (4)

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.
Measured: Day 1 (first day oxytocin or placebo was administered)
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.
Measured: Day 1 (first day oxytocin or placebo was administered)
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.
Measured: Day 1 (first day oxytocin or placebo was administered)
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.
Measured: Day 1 (first day oxytocin or placebo was administered)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Aug 2013

First posted17 May 2013 (estimated)
Study startJul 2012
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01856530
Sponsor's protocol ID: H-31668
Status last verified: Jan 2018
First submitted: 10 May 2013
Last updated: 13 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 28559206

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Oxytocin on Pro-Social Behavior in Social Anxiety Disorder
ClinicalTrials.gov ID: NCT01856530
Acronym / sponsor ID: H-31668
Conditions: Social Anxiety Disorder
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Stefan G. HofmannUniversity, hospital or other
Study start: Jul 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 17 May 2013 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Oxytocin	Experimental	Drug: OxytocinLiquid intranasal oxytocin, 24 IU, administered once
Placebo	Placebo comparator	Drug: PlaceboMatched placebo nasal spray

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxytocinLiquid metered-dose nasal spray, 24 IU, administered once	Drug	Oxytocin
PlaceboMatched placebo nasal spray	Drug	Placebo

Primary outcome

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.
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.

4 secondary outcomes

Perceived Trust Scores on a 1-7 Likert Scale
Time frame: Day 1 (first day oxytocin or placebo was administered)
Perceived Empathy Scores on a 1-7 Likert Scale
Time frame: Day 1 (first day oxytocin or placebo was administered)
Perceived Preference Scores on a 1-7 Likert Scale
Time frame: Day 1 (first day oxytocin or placebo was administered)
Perceived Rejection Scores on a 1-7 Likert Scale
Time frame: Day 1 (first day oxytocin or placebo was administered)

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin	27	27
Placebo	27	27

Primary outcome: Social Cooperation

Time frame: Day 1 (first day oxytocin or placebo was administered). Mean (Standard Deviation). Unit: Ball tosses

Measure	Oxytocin n = 26	Placebo n = 26
Value	4.42 (6.706)	4.69 (6.078)

Population analysed: Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54.

Primary outcome: Disengagement From Social Threat Cues

Time frame: Day 1 (first day oxytocin or placebo was administered). Mean (Standard Deviation). Unit: Milliseconds

Measure	Oxytocin n = 27	Placebo n = 27
Value	1.34 (36.79)	-2.69 (52.39)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxytocin	0 of 27 (0%)	7 of 27 (25.9%)	Not reported
Placebo	0 of 27 (0%)	9 of 27 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28559206Fang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oxytocin in people with Social Anxiety Disorder, run by Stefan G. Hofmann at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Cooperation (time frame: Day 1 (first day oxytocin or placebo was administered)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01856530, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.