The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01466127
First received: November 2, 2011
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder |
Drug: Oxytocin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Physiological reactivity as measured by skin conductance, heart rate, and corrugator EMG [ Time Frame: Day 2 of Conditioning (1 day post Day 1 of Conditioning) ] [ Designated as safety issue: No ]Differences in physiological reactivity between the active vs. placebo conditions will be used to assess for the impact of oxytocin on fear renewal and reinstatement.
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Matched nasal spray placebo.
|
Drug: Placebo
Matched nasal spray placebo
|
|
Experimental: Oxytocin
Liquid intranasal oxytocin administered in a nasal spray.
|
Drug: Oxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
Other Name: Syntocinon
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466127
Locations
| United States, Massachusetts | |
| Center for Anxiety and Traumatic Disorders, MGH | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Noah Schwarz 617-724-0851 nschwarz@partners.org | |
| Principal Investigator: Elizabeth A Hoge, MD | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Elizabeth A Hoge, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01466127 History of Changes |
| Other Study ID Numbers: | 2010P-002911 |
| Study First Received: | November 2, 2011 |
| Last Updated: | May 8, 2013 |
| Health Authority: | 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:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Oxytocin |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013