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

Not Applicable
Completed
Conditions
Posttraumatic Stress Disorder
Interventions
Drug: Placebo
Registration Number
NCT01466127
Lead Sponsor
Massachusetts General Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboMatched nasal spray placebo.
OxytocinOxytocinLiquid intranasal oxytocin administered in a nasal spray.
Primary Outcome Measures
NameTimeMethod
Differential Skin Conductance Response (SCR) During the First Two Extinction TrialsDay 2 of Conditioning (1 day post Day 1 of Conditioning)

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
NameTimeMethod

Trial Locations

Locations (1)

Center for Anxiety and Traumatic Disorders, MGH

🇺🇸

Boston, Massachusetts, United States

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