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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01466127
First received: November 2, 2011
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Drug: Oxytocin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Physiological reactivity as measured by skin conductance, heart rate, and corrugator EMG [ Time Frame: Day 2 of Conditioning (1 day post Day 1 of Conditioning) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matched nasal spray placebo.
Drug: Placebo
Matched nasal spray placebo
Experimental: Oxytocin
Liquid intranasal oxytocin administered in a nasal spray.
Drug: Oxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
Other Name: Syntocinon

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466127

Locations
United States, Massachusetts
Center for Anxiety and Traumatic Disorders, MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01466127     History of Changes
Other Study ID Numbers: 2010P-002911
Study First Received: November 2, 2011
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Effect of oxytocin on learning

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014