The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)

Posttraumatic Stress Disorder Clinical Trial

Official title:

The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466127
• Other study ID #: 2010P-002911
• Status: Completed
• Phase: N/A
• First received: November 2, 2011
• Last updated: May 29, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men or women 18 to 65 years of age

• Score in study range on the NEO-FFI

• No current Axis I DSM-IV excluded diagnoses as determined by the SCID completed within the past 4 months.

• Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures.

• Subjects must be able to give informed consent and be willing and able to comply with study procedures.

Exclusion Criteria:

• Presence of a current DSM-IV Axis I diagnosis as measured by the SCID.

• A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult.

• Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).

• Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics.

• Pregnant or lactating women.

• Women of childbearing potential not using medically accepted forms of contraception.

• Current use of the excluded psychiatric medications.

• Known hypersensitivity to oxytocin

• Known hyponatremia.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Oxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
• Placebo
Matched nasal spray placebo

Locations

Country	Name	City	State
United States	Center for Anxiety and Traumatic Disorders, MGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological reactivity as measured by skin conductance, heart rate, and corrugator EMG	Differences in physiological reactivity between the active vs. placebo conditions will be used to assess for the impact of oxytocin on fear renewal and reinstatement.	Day 2 of Conditioning (1 day post Day 1 of Conditioning)	No