Body Dysmorphic DisorderPhase 2NCT02671266
Oxytocin Administration in BDD and OCD
A Phase 2 study testing Oxytocin in people with Body Dysmorphic Disorder and Obsessive-compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Dysmorphic Disorder, Obsessive-compulsive Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2017
- Phase
- Phase 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Treatment-seeking adult males and females ≥ 18 years of age
- Meets DSM-IV criteria for principal BDD (for BDD group) or principal OCD (for OCD group), as determined by Structured Clinical Interview for DSM-IV (SCID) diagnostic interview
- For females only: must be taking low-dose oral contraceptive pills, as defined by monophasic pills containing <50 mcg ethinyl estradiol
- For healthy volunteers only: does not meet current DSM-IV diagnosis of any Axis I disorder
Who cannot join
- Participants in the BDD group will be excluded if they have a comorbid diagnosis of OCD and participants in the OCD group will be excluded if they have a comorbid diagnosis of BDD.
- Current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, substance abuse or substance dependence. All other Axis I comorbidities will be permitted to foster the accrual of a clinically relevant sample.
- Significant nasal pathology (e.g., atrophic rhinitis, history of hypophysectomy, recurrent nosebleeds)
- Smokers who smoke ≥ 15 cigarettes daily
- Serious medical illnesses
- Active homicidal or suicidal ideation
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- Concurrent use of psychotropic medications
- Steroid or hormone use (except low-dose oral contraceptive pills for females, which is allowed)
- For females only: positive urine pregnancy test and use of high dose estrogen/progestin pills (low dose estrogen/progestin oral contraceptives will be allowed due to stability of hormone levels during active phase)
- For healthy volunteers only: any current DSM-IV Axis I disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital/Harvard Medical School
Boston, Massachusetts, 02114
About this study
Official title: Effect of Intranasal Oxytocin on Social Cognition
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.
Read the detailed description
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.
- Being tested
- Oxytocin, Placebo
- Keywords
- Oxytocin, Body dysmorphic disorder, Obsessive-compulsive disorder
- Medical subject headings
- Body Dysmorphic Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon (Novartis Switzerland)
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.
PlaceboDrug
Also called Matching placebo formulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Oxytocin; Drug: Placebo |
| 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). Receives: Drug: Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 minutes post nasal spray administration
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: At least 45 minutes post nasal spray administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startDec 2014
- Primary completionOct 2017
- Study completionOct 2017
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.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Wilhelm, Massachusetts General Hospital
- Investigators
- Angela Fang, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671266
- Sponsor's protocol ID
- 2014P001777
- Status last verified
- Nov 2018
- First submitted
- 12 Jan 2016
- Last updated
- 23 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Oxytocin on Social Cognition
- ClinicalTrials.gov ID
- NCT02671266
- Acronym / sponsor ID
- 2014P001777
- Keywords
- Oxytocin, Body dysmorphic disorder, Obsessive-compulsive disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin, Then Placebo | Experimental | Drug: Oxytocin, Drug: PlaceboParticipants 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). |
| Placebo, Then Oxytocin | Experimental | Drug: Oxytocin, Drug: PlaceboParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment-seeking adult males and females ≥ 18 years of age
- Meets DSM-IV criteria for principal BDD (for BDD group) or principal OCD (for OCD group), as determined by Structured Clinical Interview for DSM-IV (SCID) diagnostic interview
- For females only: must be taking low-dose oral contraceptive pills, as defined by monophasic pills containing <50 mcg ethinyl estradiol
- For healthy volunteers only: does not meet current DSM-IV diagnosis of any Axis I disorder
Key exclusion criteria (10 listed)
- Participants in the BDD group will be excluded if they have a comorbid diagnosis of OCD and participants in the OCD group will be excluded if they have a comorbid diagnosis of BDD.
- Current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, substance abuse or substance dependence. All other Axis I comorbidities will be permitted to foster the accrual of a clinically relevant sample.
- Significant nasal pathology (e.g., atrophic rhinitis, history of hypophysectomy, recurrent nosebleeds)
- Smokers who smoke ≥ 15 cigarettes daily
- Serious medical illnesses
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 |
|---|---|---|
| OxytocinAlso: Syntocinon (Novartis Switzerland)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. | Drug | Oxytocin, Then Placebo, Placebo, Then Oxytocin |
| PlaceboAlso: Matching placebo formulationPlacebo 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. | Drug | Oxytocin, Then Placebo, Placebo, Then Oxytocin |
Primary outcome
Emotion Recognition Questionnaire
Time frame: 45 minutes post nasal spray administration
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.
3 secondary outcomes
Interpretation Questionnaire
Time frame: At least 45 minutes post nasal spray administration
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
Time frame: At least 45 minutes post nasal spray administration
Amount of Initial Monetary Transfer During Trust Game
Time frame: At least 45 minutes post nasal spray administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Angela Fang, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Body Dysmorphic Disorder and Obsessive-compulsive Disorder, run by Massachusetts General Hospital 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 10 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 23 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 23 Nov 2018). 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?
Emotion Recognition Questionnaire (time frame: 45 minutes post nasal spray administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2018.