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

This study has been completed.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01466127
First received: November 2, 2011
Last updated: March 3, 2017
Last verified: March 2017
Results First Received: November 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Basic Science
Condition: Posttraumatic Stress Disorder
Interventions: Drug: Oxytocin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo

Matched nasal spray placebo.

Placebo: Matched nasal spray placebo

Oxytocin

Liquid intranasal oxytocin administered in a nasal spray.

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


Participant Flow:   Overall Study
    Placebo   Oxytocin
STARTED   30   30 
COMPLETED   16   14 
NOT COMPLETED   14   16 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Although 60 participants were enrolled, only 30 participants had usable physiological data from recording electrodes, and therefore, the only data analyzed were from these 30 participants (16 placebo and 14 oxytocin).

Reporting Groups
  Description
Placebo

Matched nasal spray placebo.

Placebo: Matched nasal spray placebo

Oxytocin

Liquid intranasal oxytocin administered in a nasal spray.

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

Total Total of all reporting groups

Baseline Measures
   Placebo   Oxytocin   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16 100.0%      14 100.0%      30 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.9  (14.7)   39.9  (15.8)   35.6  (15.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  50.0%      6  42.9%      14  46.7% 
Male      8  50.0%      8  57.1%      16  53.3% 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elizabeth Hoge, M.D.
Organization: Massachusetts General Hospital
phone: 617-724-0859
e-mail: ehoge@mgh.harvard.edu



Responsible Party: Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01466127     History of Changes
Other Study ID Numbers: 2010P-002911
Study First Received: November 2, 2011
Results First Received: November 4, 2016
Last Updated: March 3, 2017