Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

NCT01551303 | Completed Results

• 1 other identifier: 2009P-000387
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how emotional processing may be affected by a hormone called oxytocin. Oxytocin is a hormone that occurs naturally in the body, and may play an important role in the way that the brain perceives information.

Conditions

Social Intelligence

Outcome Measures

Primary Outcomes (1)

• Affective Ratings in Affective Learning Task

  We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so "better" or "worse" outcome.

  30 minutes after drug administration

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched nasal spray placebo.

Drug: Placebo

Oxytocin

EXPERIMENTAL

Liquid intranasal oxytocin administered in a nasal spray.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Liquid metered-dose nasal spray, 30 IUs, administered once.

Also known as: Syntocinon

Oxytocin

Placebo DRUG

Matched nasal spray placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• No current Axis I according to Diagnostic \& Statistical Manual for Psychiatry-IV excluded diagnoses as determined by MINI or Structured Clinical Interview for Diagnosis psychiatric diagnostic interview completed within the past 6 months
• Age 18 to 65
• Subjects must be able to give informed consent and be willing and able to comply with study procedures.

You may not qualify if:

• Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months
• Pregnant or lactating women.
• Subjects currently taking hormones, such as estrogen.
• Known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray.
• Known hyponatremia or concurrent use of diuretics.
• Subjects with a history of seizure disorder.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Center for Anxiety and Traumatic Stress Disorders (CATSD)

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Oxytocin

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. Elizabeth Hoge
• Organization: Massachusetts General Hospital

ehoge@partners.org

617-724-0859

Study Officials

• Elizabeth A Hoge, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Psychiatrist

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 12, 2012
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-03

Locations

US (1)