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

NCT01466127 | Completed Results

• 1 other identifier: 2010P-002911
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Effect of oxytocin on learning

Outcome Measures

Primary Outcomes (1)

• Differential Skin Conductance Response (SCR) During the First Two Extinction Trials

  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.

  Day 2 of Conditioning (1 day post Day 1 of Conditioning)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched nasal spray placebo.

Drug: Placebo

Oxytocin

EXPERIMENTAL

Liquid intranasal oxytocin administered in a nasal spray.

Drug: Oxytocin

Interventions

Oxytocin DRUG

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

Also known as: Syntocinon

Oxytocin

Placebo DRUG

Matched nasal spray placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Department of Defense: collaborator

Study Sites (1)

Center for Anxiety and Traumatic Disorders, MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Elizabeth Hoge, M.D.
• Organization: Massachusetts General Hospital

ehoge@mgh.harvard.edu

617-724-0859

Study Officials

• Elizabeth A Hoge, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 7, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

US (1)