Phase 2 Completed N=41 Randomized Double-blind Other

Oxytocin Administration in BDD and OCD

Body Dysmorphic Disorder · Obsessive-compulsive disorder

Source: ClinicalTrials.gov NCT02671266 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcomePrimary: Emotion Recognition Questionnaire — 18.67; 17.00; 17.00; 16.40 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Emotion Recognition Questionnaire	18.67; 17.00; 17.00; 16.40; 18.00; 18.30	—
SECONDARY Interpretation Questionnaire	24.88; 26.75; 27.25; 33.25; 20.88; 22.38	—
SECONDARY Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task	636.56; 689.32; 624.08; 581.47; 626.80; 594.96	—
SECONDARY Amount of Initial Monetary Transfer During Trust Game	6.11; 7.67; 7.11; 8.00; 7.22; 6.89	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02671266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.