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Influence of Escitalopram on Fear Conditioning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398514
First Posted: July 20, 2011
Last Update Posted: June 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
Results First Submitted: July 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Fear Conditioning
Intervention: Drug: Escitalopram

  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
Participants free of DSM-IV Axis I disorders with varying levels of subsyndromal anxiety were recruited by advertisements (e.g., postings on Craigslist, postings on Massachusetts General Hospital research participation registry) from March 2009 through April 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
65 participants signed consent and were screened for enrollment. 10 participants did not meet study entry criteria due to exclusionary psychiatric conditions. Of the 55 eligible participants, 3 withdrew and 1 was lost to follow up. 52 participants were randomly assigned to a treatment arm. Fourteen were excluded from analyses.

Reporting Groups
  Description
Active Medication Escitalopram 10mg/day
Placebo Matched pill placebo

Participant Flow:   Overall Study
    Active Medication   Placebo
STARTED   26   26 
COMPLETED   18   20 
NOT COMPLETED   8   6 
Adverse Event                1                0 
Non-compliance with study procedures                2                0 
Physiologic non-responsiveness                1                3 
Failure to show a conditioned response                4                3 



  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
Active Medication Escitalopram 10mg/day
Placebo Matched pill placebo
Total Total of all reporting groups

Baseline Measures
   Active Medication   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   26   52 
Age 
[Units: Participants]
     
<=18 years   1   0   1 
Between 18 and 65 years   25   26   51 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.04  (11.56)   30.46  (11.46)   32.25  (11.54) 
Gender 
[Units: Participants]
     
Female   14   12   26 
Male   12   14   26 
Region of Enrollment 
[Units: Participants]
     
United States   26   26   52 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4   [ Time Frame: Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation) ]

2.  Primary:   Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5   [ Time Frame: Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation) ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Naomi Simon
Organization: Massachusetts General Hospital
phone: 617-726-7913
e-mail: nsimon@partners.org



Responsible Party: Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01398514     History of Changes
Other Study ID Numbers: 2008-P-001314
First Submitted: July 12, 2011
First Posted: July 20, 2011
Results First Submitted: July 25, 2013
Results First Posted: September 27, 2013
Last Update Posted: June 11, 2014