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
About this trial
This is an interventional basic science trial for Posttraumatic Stress Disorder focused on measuring Effect of oxytocin on learning
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.
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
NCT ID
NCT01466127
First Posted
November 2, 2011
Last Updated
March 3, 2017
Sponsor
Massachusetts General Hospital
Collaborators
United States Department of Defense
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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