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

NCT ID: NCT01466127

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-05-31

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Matched nasal spray placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched nasal spray placebo

Oxytocin

Liquid intranasal oxytocin administered in a nasal spray.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Liquid metered-dose nasal spray, 30 IUs, administered once.

Interventions

Oxytocin

Liquid metered-dose nasal spray, 30 IUs, administered once.

Intervention Type: DRUG

Placebo

Matched nasal spray placebo

Intervention Type: DRUG

Other Intervention Names

Syntocinon

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth A. Hoge, MD

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A Hoge, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Center for Anxiety and Traumatic Disorders, MGH

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010P-002911

Identifier Type: -

Identifier Source: org_study_id