N/A
N=60
The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01466127 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Differential Skin Conductance Response (SCR) During the First Two Extinction Trials — 0.15; 0.00 micro-Siemens (square rooted) — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differential Skin Conductance Response (SCR) During the First Two Extinction Trials |
0.15; 0.00 | 0.28 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01466127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.