Clinical trial NCT02671266: Oxytocin Administration in BDD and OCD
Official title: Effect of Intranasal Oxytocin on Social Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Body Dysmorphic Disorder
Obsessive-compulsive Disorder
Keywords: Oxytocin
Body dysmorphic disorder
Obsessive-compulsive disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Emotion Recognition Questionnaire
timeFrame: 45 minutes post nasal spray administration
Secondary outcomes:
measure: Interpretation Questionnaire
timeFrame: At least 45 minutes post nasal spray administration
measure: Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
timeFrame: At least 45 minutes post nasal spray administration
measure: Amount of Initial Monetary Transfer During Trust Game
timeFrame: At least 45 minutes post nasal spray administration
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital/Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Angela Fang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: