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Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01551303
First received: February 21, 2012
Last updated: May 29, 2014
Last verified: March 2014
Results First Received: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Social Intelligence
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
Adults aged 18 to 65 were recruited to the Massachusetts General Hospital through local email and print media advertising from March 2011 to September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled participants were excluded before group assignment.

Reporting Groups
  Description
Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal
Placebo Placebo, 0.77 ml, intranasal

Participant Flow:   Overall Study
    Oxytocin     Placebo  
STARTED     25     22  
COMPLETED     21     15  
NOT COMPLETED     4     7  
failed awareness check on vision test                 4                 7  



  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.
No text entered.

Reporting Groups
  Description
Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal
Placebo Placebo, 0.77 ml, intranasal
Total Total of all reporting groups

Baseline Measures
    Oxytocin     Placebo     Total  
Number of Participants  
[units: participants]
  25     22     47  
Age  
[units: years]
Mean ± Standard Deviation
  42.24  ± 11.61     44.50  ± 9.62     43.30  ± 10.67  
Gender  
[units: participants]
     
Female     10     8     18  
Male     15     14     29  
Region of Enrollment  
[units: participants]
     
United States     25     22     47  



  Outcome Measures

1.  Primary:   Affective Ratings in Affective Learning Task   [ Time Frame: 30 minutes after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Dr. Elizabeth Hoge
Organization: Massachusetts General Hospital
phone: 617-724-0859
e-mail: ehoge@partners.org


No publications provided


Responsible Party: Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01551303     History of Changes
Other Study ID Numbers: 2009P-000387
Study First Received: February 21, 2012
Results First Received: March 26, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration