Oxytocin Administration in BDD and OCD

NCT ID: NCT02671266

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-10-31

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.

Conditions

Body Dysmorphic Disorder; Obsessive-compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin, Then Placebo

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).

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: 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.

Placebo

Intervention Type: 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.

Placebo, Then Oxytocin

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).

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: 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.

Placebo

Intervention Type: 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.

Interventions

Oxytocin

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Syntocinon (Novartis Switzerland); Matching placebo formulation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabine Wilhelm

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Fang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital/Harvard Medical School

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014P001777

Identifier Type: -

Identifier Source: org_study_id