Phase 2
N=41
Oxytocin Administration in BDD and OCD
Body Dysmorphic Disorder · Obsessive-compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02671266 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Emotion Recognition Questionnaire — 18.67; 17.00; 17.00; 16.40 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2017
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 | — |
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 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
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.