Oxytocin Administration in BDD and OCD

NCT02671266 | Completed Phase 2 Results DMC

• 1 other identifier: 2014P001777
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Dysmorphic Disorder; Obsessive-compulsive Disorder

Keywords

Oxytocin; Body dysmorphic disorder; Obsessive-compulsive disorder

Outcome Measures

Primary Outcomes (1)

• Emotion Recognition Questionnaire

  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.

  45 minutes post nasal spray administration

Secondary Outcomes (3)

• 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 Arms (2)

Oxytocin, Then Placebo

EXPERIMENTAL

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).

Drug: Oxytocin; Drug: Placebo

Placebo, Then Oxytocin

EXPERIMENTAL

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).

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.

Also known as: Syntocinon (Novartis Switzerland)

Oxytocin, Then Placebo; Placebo, Then Oxytocin

Placebo DRUG

Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.

Also known as: Matching placebo formulation

Oxytocin, Then Placebo; Placebo, Then Oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital/Harvard Medical School

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Body Dysmorphic Disorders; Obsessive-Compulsive Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Angela Fang
• Organization: Massachusetts General Hospital/Harvard Medical School

afang@mgh.harvard.edu

617-643-7717

Study Officials

• Angela Fang, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 2, 2016
• Study Start: December 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)