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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01466127
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Drug: Oxytocin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Syntocinon

Outcome Measures

Primary Outcome Measures

1. Differential Skin Conductance Response (SCR) During the First Two Extinction Trials [Day 2 of Conditioning (1 day post Day 1 of Conditioning)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Anxiety and Traumatic Disorders, MGH	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• United States Department of Defense

Investigators

• Principal Investigator: Elizabeth A Hoge, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01466127
• Other Study ID Numbers: 2010P-002911
• First Posted: Nov 6, 2011
• Last Update Posted: Apr 14, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital: Effect of oxytocin on learning
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Oxytocin

Study Results

Participant Flow

Arm/Group Title	Placebo	Oxytocin
Arm/Group Description	Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Period Title: Overall Study
STARTED	30	30
COMPLETED	16	14
NOT COMPLETED	14	16

Baseline Characteristics

Arm/Group Title	Placebo	Oxytocin	Total
Arm/Group Description	Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.	Total of all reporting groups
Overall Participants	16	14	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	14 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	31.9 (14.7)	39.9 (15.8)	35.6 (15.5)
Sex: Female, Male (Count of Participants)
Female	8 50%	6 42.9%	14 46.7%
Male	8 50%	8 57.1%	16 53.3%
Region of Enrollment (participants) [Number]
United States	16 100%	14 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
Description	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.
Time Frame	Day 2 of Conditioning (1 day post Day 1 of Conditioning)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Oxytocin
Arm/Group Description	Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Measure Participants	16	14
Mean (Standard Deviation) [micro-Siemens (square rooted)]	0.15 (0.31)	0.00 (0.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Oxytocin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Placebo		Oxytocin
Arm/Group Description	Matched nasal spray placebo. Placebo: Matched nasal spray placebo		Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
All Cause Mortality
	Placebo		Oxytocin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Oxytocin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Oxytocin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		0/14 (0%)
Skin and subcutaneous tissue disorders
Bloody Nose	1/16 (6.3%)	1	0/14 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.