A Phase 2 interventional study of Oxytocin and Placebo in Body Dysmorphic Disorder and Obsessive-compulsive Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-23.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Other
The purpose of the current study is to investigate the effect of an acute administration of intranasal oxytocin, relative to placebo, on social cognitive impairments among individuals with body dysmorphic disorder and obsessive-compulsive disorder, compared to healthy controls.
Despite the development of efficacious pharmacologic and psychological treatments body dysmorphic disorder (BDD), treatment outcome data suggest that there is still considerable room for improvement. A closer examination of biological mechanisms underlying psychopathology may help uncover mechanisms to target during intervention and thereby provide a novel approach to treatment. Given that the neuropeptide, oxytocin, is involved in the regulation of a variety of social and cognitive dimensions, including emotion recognition and social attentional processing, there are direct implications regarding its role in the development of such deficits among individuals with BDD. The current study therefore aims to investigate the effect of oxytocin administration on social cognitive impairments in BDD and a related disorder, OCD. Twenty treatment-seeking male and female outpatients with BDD, 20 individuals with OCD, and 20 healthy participants will be assigned to receive an oxytocin and placebo nasal spray one week apart. During each visit, subjects will complete a series of tasks to measure emotion recognition, attentional biases, interpretive biases, and trust behavior. Importantly, these findings may show that a single administration of oxytocin may alter social cognitive processes thought to maintain BDD, and ultimately inform treatments for BDD.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 41 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Drug: Oxytocin · Drug: Placebo
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Drug: Oxytocin · Drug: Placebo
Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Also known as: Syntocinon (Novartis Switzerland)
Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
Also known as: Matching placebo formulation
Emotion Recognition Questionnaire
This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.
Time frame: 45 minutes post nasal spray administration
Interpretation Questionnaire
This questionnaire includes 33 ambiguous scenarios, representing 3 conditions: BDD threat scenarios, social anxiety threat scenarios, and general threat scenarios. Each item involves 3 possible thoughts that may come to mind in the scenarios which reflect positive, negative, and neutral interpretations. Participants will be asked to rate the likelihood of having each of the thoughts on a scale of 0 (very unlikely) to 4 (very likely). Total scores are reported for negative threat interpretations for each of the 3 conditions (BDD threat, social anxiety threat, general threat), with scores ranging from 0 (very unlikely) to 44 (very likely).
Time frame: At least 45 minutes post nasal spray administration
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
The outcome measures are response latencies (in milliseconds) on engagement and disengagement trials for disgust, happy, and neutral cue types. Longer response latencies reflect more sustained attention.
Time frame: At least 45 minutes post nasal spray administration
Amount of Initial Monetary Transfer During Trust Game
Participants will have the decision of sending between 0 to 10 game dollars to another participant, without any expectation of monetary return. This initial investment amount will serve as a measure of trust, with a transfer of 0 game dollars indicating no trust and a transfer of 10 game dollars indicating maximum trust.
Time frame: At least 45 minutes post nasal spray administration
| Milestone | Oxytocin, Then Placebo | Placebo, Then Oxytocin |
|---|---|---|
| Started | 20 | 21 |
| Bdd participants | 9 | 9 |
| Ocd participants | 2 | 3 |
| Healthy participants | 8 | 8 |
| Completed | 19 | 20 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.
| score on a scale | Oxytocin, Then Placebo | Placebo, Then Oxytocin |
|---|---|---|
| BDD oxytocin- self-referent | 18.67 ± 3.16 | 17.00 ± 6.41 |
| BDD placebo- self-referent | 17.00 ± 3.64 | 16.40 ± 6.38 |
| BDD oxytocin- other-referent | 18.00 ± 2.40 | 18.30 ± 6.77 |
| BDD placebo- other-referent | 18.44 ± 2.96 | 16.40 ± 6.15 |
| HC oxytocin- self-referent | 15.67 ± 6.00 | 17.13 ± 3.76 |
| HC placebo- self-referent | 15.88 ± 6.64 | 18.88 ± 3.83 |
| HC oxytocin- other-referent | 14.78 ± 5.74 | 16.25 ± 6.90 |
| HC placebo- other-referent | 16.00 ± 6.52 | 17.88 ± 3.36 |
This questionnaire includes 33 ambiguous scenarios, representing 3 conditions: BDD threat scenarios, social anxiety threat scenarios, and general threat scenarios. Each item involves 3 possible thoughts that may come to mind in the scenarios which reflect positive, negative, and neutral interpretations. Participants will be asked to rate the likelihood of having each of the thoughts on a scale of 0 (very unlikely) to 4 (very likely). Total scores are reported for negative threat interpretations for each of the 3 conditions (BDD threat, social anxiety threat, general threat), with scores ranging from 0 (very unlikely) to 44 (very likely).
| score on a scale | Oxytocin, Then Placebo | Placebo, Then Oxytocin |
|---|---|---|
| Oxytocin BDD- BDD threat | 24.88 ± 8.51 | 26.75 ± 13.50 |
| Oxytocin BDD- SA threat | 27.25 ± 4.06 | 33.25 ± 16.29 |
| Oxytocin BDD- Gen threat | 20.88 ± 8.48 | 22.38 ± 6.46 |
| Placebo BDD- BDD threat | 21.88 ± 10.03 | 28.78 ± 9.01 |
| Placebo BDD- SA threat | 25.75 ± 7.76 | 31.11 ± 6.37 |
| Placebo BDD- Gen threat | 19.88 ± 8.13 | 24.33 ± 7.86 |
| Oxytocin HC- BDD threat | 10.13 ± 5.94 | 8.50 ± 9.09 |
| Oxytocin HC- SA threat | 13.38 ± 5.55 | 12.90 ± 9.58 |
| Oxytocin HC- Gen threat | 16.75 ± 6.50 | 15.38 ± 9.13 |
| Placebo HC- BDD threat | 7.71 ± 4.31 | 7.88 ± 5.59 |
| Placebo HC- SA threat | 15.86 ± 5.11 | 12.88 ± 7.85 |
| Placebo HC- Gen threat | 19.41 ± 4.82 | 13.63 ± 8.45 |
The outcome measures are response latencies (in milliseconds) on engagement and disengagement trials for disgust, happy, and neutral cue types. Longer response latencies reflect more sustained attention.
| milliseconds | Oxytocin, Then Placebo | Placebo, Then Oxytocin |
|---|---|---|
| BDD Oxytocin Happy Engagement | 636.56 ± 66.07 | 689.32 ± 282.68 |
| BDD Oxytocin Happy Disengagement | 624.08 ± 78.21 | 581.47 ± 67.98 |
| BDD Oxytocin Neutral Disengagement | 626.80 ± 74.58 | 594.96 ± 92.18 |
| BDD Oxytocin Neutral Engagement | 649.77 ± 65.46 | 737.74 ± 361.07 |
| BDD Oxytocin Disgust Disengagement | 622.30 ± 77.45 | 607.09 ± 111.39 |
| BDD Oxytocin Disgust Engagement | 674.00 ± 95.03 | 603.94 ± 83.59 |
| BDD Placebo Happy Engagement | 587.86 ± 57.84 | 718.41 ± 401.92 |
| BDD Placebo Happy Disengagement | 627.45 ± 106.07 | 610.25 ± 95.03 |
| BDD Placebo Neutral Disengagement | 590.84 ± 55.10 | 604.59 ± 62.14 |
| BDD Placebo Neutral Engagement | 626.99 ± 116.93 | 614.46 ± 79.94 |
| BDD Placebo Disgust Disengagement | 604.24 ± 63.82 | 601.19 ± 66.31 |
| BDD Placebo Disgust Engagement | 593.57 ± 52.72 | 625.31 ± 119.00 |
| HC Oxytocin Happy Engagement | 622.08 ± 75.20 | 984.01 ± 452.85 |
| HC Oxytocin Happy Disengagement | 634.15 ± 80.27 | 881.50 ± 270.97 |
| HC Oxytocin Neutral Engagement | 656.64 ± 120.41 | 871.63 ± 336.02 |
| HC Oxytocin Neutral Disengagement | 644.85 ± 137.26 | 781.01 ± 231.04 |
| HC Oxytocin Disgust Disengagement | 613.12 ± 72.78 | 834.81 ± 219.30 |
| HC Oxytocin Disgust Engagement | 620.73 ± 75.60 | 826.90 ± 208.97 |
| HC Placebo Happy Engagement | 593.97 ± 73.17 | 811.25 ± 200.97 |
| HC Placebo Happy Disengagement | 576.44 ± 78.04 | 919.46 ± 268.07 |
| HC Placebo Neutral Disengagement | 575.38 ± 108.46 | 774.14 ± 150.24 |
| HC Placebo Neutral Engagement | 571.02 ± 84.09 | 847.44 ± 182.60 |
| HC Placebo Disgust Disengagement | 603.58 ± 106.17 | 896.73 ± 238.16 |
| HC Placebo Disgust Engagement | 560.64 ± 52.51 | 864.02 ± 215.64 |
Participants will have the decision of sending between 0 to 10 game dollars to another participant, without any expectation of monetary return. This initial investment amount will serve as a measure of trust, with a transfer of 0 game dollars indicating no trust and a transfer of 10 game dollars indicating maximum trust.
| units on a scale | Oxytocin, Then Placebo | Placebo, Then Oxytocin |
|---|---|---|
| Oxytocin BDD- Game 1 | 6.11 ± 2.67 | 7.67 ± 2.50 |
| Placebo BDD- Game 1 | 7.11 ± 2.33 | 8.00 ± 2.50 |
| Oxytocin BDD- Game 2 | 7.22 ± 2.33 | 6.89 ± 3.51 |
| Placebo BDD- Game 2 | 5.22 ± 3.35 | 8.00 ± 2.50 |
| Oxytocin HC- Game 1 | 6.25 ± 2.49 | 7.75 ± 2.19 |
| Placebo HC- Game 1 | 7.71 ± 2.06 | 5.50 ± 3.12 |
| Oxytocin HC- Game 2 | 7.88 ± 1.64 | 6.88 ± 2.75 |
| Placebo HC- Game 2 | 8.29 ± 1.38 | 5.50 ± 3.12 |
Collected over Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxytocin | 0/34 (0%) | 0/34 (0%) | 15/34 (44.1%) |
| Placebo | 0/33 (0%) | 0/33 (0%) | 17/33 (51.5%) |
| Event | Oxytocin | Placebo |
|---|---|---|
| Feeling drowsy or sleepyNervous system disorders | 12/34 | 11/33 |
| HeadacheNervous system disorders | 3/34 | 7/33 |
| Difficulty sitting stillNervous system disorders | 7/34 | 4/33 |
| Feeling of calmness or euphoriaNervous system disorders | 6/34 | 6/33 |
| LightheadednessNervous system disorders | 2/34 | 4/33 |
| Trouble concentratingNervous system disorders | 4/34 | 2/33 |
| Dry mouth/throatNervous system disorders | 2/34 | 3/33 |
| Anxiety or depressionNervous system disorders | 3/34 | 2/33 |
| Nasal irritationRespiratory, thoracic and mediastinal disorders | 3/34 | 0/33 |
| Poor memoryNervous system disorders | 0/34 | 2/33 |
| Age, Continuous(years) | Oxytocin, Then Placebo | Placebo, Then Oxytocin | Total |
|---|---|---|---|
| Mean | 27.20 ± 8.90 | 27.05 ± 7.00 | 27.12 ± 7.88 |
| Sex: Female, Male(Participants) | Oxytocin, Then Placebo | Placebo, Then Oxytocin | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 13 | 13 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Oxytocin, Then Placebo | Placebo, Then Oxytocin | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 17 | 21 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Oxytocin, Then Placebo | Placebo, Then Oxytocin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 6 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 14 | 14 | 28 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BDD-YBOCS(units on a scale) | Oxytocin, Then Placebo | Placebo, Then Oxytocin | Total |
|---|---|---|---|
| Mean | 25.11 ± 5.13 | 24.89 ± 3.55 | 24.89 ± 4.19 |
| BABS(units on a scale) | Oxytocin, Then Placebo | Placebo, Then Oxytocin | Total |
|---|---|---|---|
| Mean | 12.73 ± 5.82 | 11.17 ± 3.41 | 11.91 ± 4.67 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Dec 2014, a primary completion of Oct 2017 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2018, 1 year 1 month after primary completion.
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Studies of the drug tested here: Oxytocin
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