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Oxytocin Administration in BDD and OCD

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ClinicalTrials.gov Identifier: NCT02671266
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Obsessive-compulsive Disorder Drug: Oxytocin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect of Intranasal Oxytocin on Social Cognition
Study Start Date : December 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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).
Drug: 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.
Other Name: Syntocinon (Novartis Switzerland)

Drug: 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.
Other Name: Matching placebo formulation

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).
Drug: 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.
Other Name: Syntocinon (Novartis Switzerland)

Drug: 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.
Other Name: Matching placebo formulation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Interpretation Questionnaire [ Time Frame: At least 45 minutes post nasal spray administration ]
    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).

  2. Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task [ Time Frame: At least 45 minutes post nasal spray administration ]
    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.

  3. Amount of Initial Monetary Transfer During Trust Game [ Time Frame: At least 45 minutes post nasal spray administration ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671266


Locations
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United States, Massachusetts
Massachusetts General Hospital/Harvard Medical School
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Angela Fang, Ph.D. Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Sabine Wilhelm, Massachusetts General Hospital:
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Responsible Party: Sabine Wilhelm, Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02671266    
Other Study ID Numbers: 2014P001777
First Posted: February 2, 2016    Key Record Dates
Results First Posted: November 23, 2018
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sabine Wilhelm, Massachusetts General Hospital:
Oxytocin
Body dysmorphic disorder
Obsessive-compulsive disorder
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Body Dysmorphic Disorders
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Somatoform Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs