The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
This study has been completed.
Department of Defense
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
First received: November 2, 2011
Last updated: May 29, 2014
Last verified: May 2014
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.
Posttraumatic Stress Disorder
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
||The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Matched nasal spray placebo.
Matched nasal spray placebo
Liquid intranasal oxytocin administered in a nasal spray.
Liquid metered-dose nasal spray, 30 IUs, administered once.
Other Name: Syntocinon
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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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
|Center for Anxiety and Traumatic Disorders, MGH
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
Department of Defense
||Elizabeth A Hoge, MD
||Massachusetts General Hospital
No publications provided
||Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 2011
||May 29, 2014
||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:
ClinicalTrials.gov processed this record on October 08, 2015
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Physiological Effects of Drugs
Reproductive Control Agents