Oxytocin Administration in BDD and OCD

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.

Study Overview

• Status: Completed
• Conditions: Body Dysmorphic Disorder; Obsessive-compulsive Disorder
• Intervention / Treatment: Drug: Oxytocin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital/Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: Matching placebo formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Angela Fang, Ph.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Oxytocin; Body dysmorphic disorder; Obsessive-compulsive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Somatoform Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Body Dysmorphic Disorders; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 2014P001777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No