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Clinical Trials/NCT02671266
NCT02671266
Completed
Phase 2

Effect of Intranasal Oxytocin on Social Cognition

Massachusetts General Hospital1 site in 1 country41 target enrollmentDecember 2014

Overview

Phase
Phase 2
Intervention
Oxytocin
Conditions
Body Dysmorphic Disorder
Sponsor
Massachusetts General Hospital
Enrollment
41
Locations
1
Primary Endpoint
Emotion Recognition Questionnaire
Status
Completed
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
October 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sabine Wilhelm

Professor

Massachusetts General Hospital

Eligibility 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

Arms & Interventions

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).

Intervention: Oxytocin

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).

Intervention: Placebo

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).

Intervention: Oxytocin

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).

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

  • Interpretation Questionnaire(At least 45 minutes post nasal spray administration)
  • Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task(At least 45 minutes post nasal spray administration)
  • Amount of Initial Monetary Transfer During Trust Game(At least 45 minutes post nasal spray administration)

Study Sites (1)

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