Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception

NCT ID: NCT02238379

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

Brief Summary

The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed. In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses. Brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).

Conditions

Social Perception

Study Design

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

Study Groups

Oxytocin

Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

24 International Units of Oxytocin in a Nasal Spray

Placebo

Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.

Interventions

Oxytocin

24 International Units of Oxytocin in a Nasal Spray

Intervention Type: DRUG

Placebo

Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.

Intervention Type: OTHER

Other Intervention Names

Pitocin

Eligibility Criteria

Inclusion Criteria

• Adults ages 18-64
• Good medical health
• Ability to understand and speak English

Exclusion Criteria

• Pregnancy
• Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza).
• Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
• CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness > 3 minutes.
• Medication status: Individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. The use of other psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
• A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anna Freud

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda C Mayes, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Helena JV Rutherford, PhD

Role: STUDY_DIRECTOR

Yale University

Locations

Yale Child Study Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1309012677

Identifier Type: -

Identifier Source: org_study_id