Influence of Escitalopram on Fear Conditioning

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01398514
First received: July 12, 2011
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: July 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Fear Conditioning
Intervention: Drug: Escitalopram

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01398514     History of Changes
Other Study ID Numbers: 2008-P-001314
Study First Received: July 12, 2011
Results First Received: July 25, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board