Primary outcomeMean· 45 minutes post nasal spray administration
Emotion Recognition Questionnaire
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin, Then Placebo | 18.67 | 3.16 |
| Placebo, Then Oxytocin | 17.00 | 6.41 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataOxytocin Administration in BDD and OCD
NCTNCT02671266 (opens ClinicalTrials.gov in a new tab)Other id2014P001777
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 41 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Dec 2014
- Primary completion
- Oct 2017
- Completion
- Oct 2017
- First posted
- 2 Feb 2016 (estimated)
- Last update posted
- 23 Nov 2018
- Conditions
- Body Dysmorphic Disorder · Obsessive-compulsive Disorder
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- PlaceboDrug
Arms2
Experimental
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).
Experimental
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).
Primary outcomes1
Outcomes the sponsor listed as primary.
Emotion Recognition Questionnaire
Time frame · 45 minutes post nasal spray administration
Registry description
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.
Secondary outcomes(3)
Interpretation Questionnaire
Time frame · At least 45 minutes post nasal spray administration
Registry description
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).
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
Time frame · At least 45 minutes post nasal spray administration
Registry description
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.
Amount of Initial Monetary Transfer During Trust Game
Time frame · At least 45 minutes post nasal spray administration
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeMean· At least 45 minutes post nasal spray administration
Interpretation Questionnaire
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin, Then Placebo | 24.88 | 8.51 |
| Placebo, Then Oxytocin | 26.75 | 13.50 |
Secondary outcomeMean· At least 45 minutes post nasal spray administration
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
| Group | Value (milliseconds) | Spread |
|---|---|---|
| Oxytocin, Then Placebo | 636.56 | 66.07 |
| Placebo, Then Oxytocin | 689.32 | 282.68 |
Secondary outcomeMean· At least 45 minutes post nasal spray administration
Amount of Initial Monetary Transfer During Trust Game
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin, Then Placebo | 6.11 | 2.67 |
| Placebo, Then Oxytocin | 7.67 | 2.50 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinParticipants 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. | 0 / 34 | 0 / 34 | 15 / 34 |
| 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). 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 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
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