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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin, Then Placebo | Experimental | 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). |
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| Placebo, Then Oxytocin | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 minutes post nasal spray administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Fang, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital/Harvard Medical School | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin, Then Placebo | 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). Oxytocin: 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. Placebo: 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. |
| FG001 | Placebo, Then Oxytocin | 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). Oxytocin: 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. Placebo: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin, Then Placebo | 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). Oxytocin: 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. Placebo: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data reported for BDD and healthy control participants who completed at least one drug visit. There was one patient in the oxytocin first arm who did not complete second placebo drug visit. OCD group was excluded from analyses due to difficulties with recruitment. | Posted | Mean | Standard Deviation | score on a scale | 45 minutes post nasal spray administration |
|
Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | 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). Oxytocin: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling drowsy or sleepy | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Fang | Massachusetts General Hospital/Harvard Medical School | 617-643-7717 | afang@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2017 | Jul 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Placebo | Drug | 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. |
|
|
| 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. | 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. | At least 45 minutes post nasal spray administration |
| BG001 | Placebo, Then Oxytocin | 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). Oxytocin: 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. Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BDD-YBOCS | The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item clinician administered measure that is designed to assess body dysmorphic disorder symptom severity. Total scores are reported. Total scores range from 0 (least severe) to 48 (most severe). | BDD-YBOCS was a clinician-administered measure only administered to patients with body dysmorphic disorder. | Mean | Standard Deviation | units on a scale |
|
| BABS | The Brown Assessment of Beliefs Scale (BABS) is a clinician-administered measure designed to assess degree of insight and conviction of beliefs. Total scores are reported. Total scores range from 0 (excellent insight) to 24 (lacks insight, delusional). | BABS was a clinician-administered measure that was administered to patients with body dysmorphic disorder and obsessive compulsive disorder. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo, Then Oxytocin | 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). Oxytocin: 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. Placebo: 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. |
|
|
| Secondary | 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). | One participant (who received oxytocin first) misunderstood the IQ so was excluded from analysis. One subject who received oxytocin first missed the second placebo drug visit. Another subject who received placebo first accidentally did not receive the Interpretation Questionnaire due to administration error. OCD group was excluded from analysis. | Posted | Mean | Standard Deviation | score on a scale | At least 45 minutes post nasal spray administration |
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| Secondary | 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. | Data reported for BDD and HC participants who completed at least one drug visit. One HC patient in the oxytocin first arm did not complete second placebo visit. Another HC patient in the placebo first arm had missing data from the placebo visit due to administrative error. OCD group was excluded from analyses due to difficulties with recruitment. | Posted | Mean | Standard Deviation | milliseconds | At least 45 minutes post nasal spray administration |
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| Secondary | 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. | Sample includes BDD and healthy control participants who completed at least one drug visit. OCD group was excluded from analysis due to difficulties with recruitment. | Posted | Mean | Standard Deviation | units on a scale | At least 45 minutes post nasal spray administration |
|
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|
| 0 |
| 34 |
| 0 |
| 34 |
| 15 |
| 34 |
| EG001 | 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). Placebo: 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. | 0 | 33 | 0 | 33 | 17 | 33 |
| Feeling of calmness or euphoria | Nervous system disorders | Systematic Assessment |
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| Difficulty sitting still | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Trouble concentrating | Nervous system disorders | Systematic Assessment |
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| Blurred vision | Nervous system disorders | Systematic Assessment |
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| Anxiety or depression | Nervous system disorders | Systematic Assessment |
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| Dry mouth/throat | Nervous system disorders | Systematic Assessment |
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| Nasal irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Poor memory | Nervous system disorders | Systematic Assessment |
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| Tremors or shakiness | Nervous system disorders | Systematic Assessment |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Oxytocin BDD- SA threat |
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| Oxytocin BDD- Gen threat |
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| Placebo BDD- BDD threat |
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| Placebo BDD- SA threat |
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| Placebo BDD- Gen threat |
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| Oxytocin HC- BDD threat |
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| Oxytocin HC- SA threat |
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| Oxytocin HC- Gen threat |
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| Placebo HC- BDD threat |
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| Placebo HC- SA threat |
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| Placebo HC- Gen threat |
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| BDD Oxytocin Happy Disengagement |
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| BDD Oxytocin Neutral Disengagement |
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| BDD Oxytocin Neutral Engagement |
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| BDD Oxytocin Disgust Disengagement |
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| BDD Oxytocin Disgust Engagement |
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| BDD Placebo Happy Engagement |
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| BDD Placebo Happy Disengagement |
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| BDD Placebo Neutral Disengagement |
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| BDD Placebo Neutral Engagement |
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| BDD Placebo Disgust Disengagement |
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| BDD Placebo Disgust Engagement |
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| HC Oxytocin Happy Engagement |
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| HC Oxytocin Happy Disengagement |
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| HC Oxytocin Neutral Engagement |
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| HC Oxytocin Neutral Disengagement |
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| HC Oxytocin Disgust Disengagement |
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| HC Oxytocin Disgust Engagement |
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| HC Placebo Happy Engagement |
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| HC Placebo Happy Disengagement |
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| HC Placebo Neutral Disengagement |
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| HC Placebo Neutral Engagement |
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| HC Placebo Disgust Disengagement |
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| HC Placebo Disgust Engagement |
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| Placebo BDD- Game 1 |
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| Oxytocin BDD- Game 2 |
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| Placebo BDD- Game 2 |
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| Oxytocin HC- Game 1 |
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| Placebo HC- Game 1 |
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| Oxytocin HC- Game 2 |
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| Placebo HC- Game 2 |
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