Oxytocin Administration in BDD and OCD

Last updated: November 21, 2018
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

2

Condition

Body Dysmorphic Disorder

Anxiety Disorders

Panic Disorders

Treatment

N/A

Clinical Study ID

NCT02671266
2014P001777
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 OCDgroup), as determined by Structured Clinical Interview for DSM-IV (SCID) diagnosticinterview

  • For females only: must be taking low-dose oral contraceptive pills, as defined bymonophasic pills containing <50 mcg ethinyl estradiol

  • For healthy volunteers only: does not meet current DSM-IV diagnosis of any Axis Idisorder

Exclusion

Exclusion Criteria:

  • Participants in the BDD group will be excluded if they have a comorbid diagnosis ofOCD and participants in the OCD group will be excluded if they have a comorbiddiagnosis of BDD.

  • Current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, substanceabuse or substance dependence. All other Axis I comorbidities will be permitted tofoster 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 isallowed)

  • For females only: positive urine pregnancy test and use of high doseestrogen/progestin pills (low dose estrogen/progestin oral contraceptives will beallowed due to stability of hormone levels during active phase)

  • For healthy volunteers only: any current DSM-IV Axis I disorder

Study Design

Total Participants: 41
Study Start date:
December 01, 2014
Estimated Completion Date:
October 31, 2017

Study 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.

Connect with a study center

  • Massachusetts General Hospital/Harvard Medical School

    Boston, Massachusetts 02114
    United States

    Site Not Available

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