Primary outcomeMean· Day 1 (first day oxytocin or placebo was administered)
Social Cooperation
| Group | Value (Ball tosses) | Spread |
|---|---|---|
| Oxytocin | 4.42 | 6.706 |
| Placebo | 4.69 | 6.078 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataEffect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
NCTNCT01856530 (opens ClinicalTrials.gov in a new tab)Other idH-31668
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 60 participants (actual)
- Sponsor
- Stefan G. Hofmann · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Jul 2012
- Primary completion
- Aug 2013
- Completion
- Aug 2013
- First posted
- 17 May 2013 (estimated)
- Last update posted
- 13 Feb 2018
- Conditions
- Social Anxiety Disorder
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014
- Ph 1/2
Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder
NCT01856530Jul 2012 to Aug 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- PlaceboDrug
Arms2
Experimental
Oxytocin
Liquid intranasal oxytocin, 24 IU, administered once
Placebo comparator
Placebo
Matched placebo nasal spray
Primary outcomes2
Outcomes the sponsor listed as primary.
Social Cooperation
Time frame · Day 1 (first day oxytocin or placebo was administered)
Registry 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.
Disengagement From Social Threat Cues
Time frame · Day 1 (first day oxytocin or placebo was administered)
Registry 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.
Secondary outcomes(4)
Perceived Trust Scores on a 1-7 Likert Scale
Time frame · Day 1 (first day oxytocin or placebo was administered)
Registry 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.
Perceived Empathy Scores on a 1-7 Likert Scale
Time frame · Day 1 (first day oxytocin or placebo was administered)
Registry 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.
Perceived Preference Scores on a 1-7 Likert Scale
Time frame · Day 1 (first day oxytocin or placebo was administered)
Registry 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.
Perceived Rejection Scores on a 1-7 Likert Scale
Time frame · Day 1 (first day oxytocin or placebo was administered)
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Day 1 (first day oxytocin or placebo was administered)
Disengagement From Social Threat Cues
| Group | Value (Milliseconds) | Spread |
|---|---|---|
| Oxytocin | 1.34 | 36.79 |
| Placebo | -2.69 | 52.39 |
Secondary and other outcome results(4)
Secondary outcomeMean· Day 1 (first day oxytocin or placebo was administered)
Perceived Trust Scores on a 1-7 Likert Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 4.65 | 1.47 |
| Placebo | 4.73 | 1.12 |
Secondary outcomeMean· Day 1 (first day oxytocin or placebo was administered)
Perceived Empathy Scores on a 1-7 Likert Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 4.46 | 1.39 |
| Placebo | 4.27 | 1.46 |
Secondary outcomeMean· Day 1 (first day oxytocin or placebo was administered)
Perceived Preference Scores on a 1-7 Likert Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 5.04 | 1.40 |
| Placebo | 5.04 | 1.18 |
Secondary outcomeMean· Day 1 (first day oxytocin or placebo was administered)
Perceived Rejection Scores on a 1-7 Likert Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 3.35 | 1.41 |
| Placebo | 3.65 | 1.29 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinLiquid intranasal oxytocin, 24 IU, administered once Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once | – | 0 / 27 | 7 / 27 |
| PlaceboMatched placebo nasal spray Placebo: Matched placebo nasal spray | – | 0 / 27 | 9 / 27 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2017
3 results
Working hard for oneself or others: Effects of oxytocin on reward motivation in social anxiety disorder.
Fang et al. 2017Biological psychologycited by 23
PMID 28559206PMC5949234DOI 10.1016/j.biopsycho.2017.05.015PUB-28559206
Rights unknown3 results
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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