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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Posttraumatic Stress Disorder focused on measuring Effect of oxytocin on learning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men or women 18 to 65 years of age
  • Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
  • No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (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.

Sites / Locations

  • Center for Anxiety and Traumatic Disorders, MGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Oxytocin

Arm Description

Matched nasal spray placebo.

Liquid intranasal oxytocin administered in a nasal spray.

Outcomes

Primary Outcome Measures

Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2011
Last Updated
March 3, 2017
Sponsor
Massachusetts General Hospital
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01466127
Brief Title
The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
Official Title
The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Effect of oxytocin on learning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched nasal spray placebo.
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Liquid intranasal oxytocin administered in a nasal spray.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
Liquid metered-dose nasal spray, 30 IUs, administered once.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched nasal spray placebo
Primary Outcome Measure Information:
Title
Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
Description
Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.
Time Frame
Day 2 of Conditioning (1 day post Day 1 of Conditioning)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men or women 18 to 65 years of age Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI) No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Hoge, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Traumatic Disorders, MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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