Influence of Escitalopram on Fear Conditioning
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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. |
ClinicalTrials.gov Identifier: NCT01398514 |
Recruitment Status :
Completed
First Posted : July 20, 2011
Results First Posted : September 27, 2013
Last Update Posted : June 11, 2014
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Sponsor:
Massachusetts General Hospital
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science |
Condition |
Fear Conditioning |
Intervention |
Drug: Escitalopram |
Enrollment | 65 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | Active Medication | Placebo |
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Escitalopram 10mg/day | Matched pill placebo |
Period Title: Overall Study | ||
Started | 26 | 26 |
Completed | 18 | 20 |
Not Completed | 8 | 6 |
Reason Not Completed | ||
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
Arm/Group Title | Active Medication | Placebo | Total | |
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Escitalopram 10mg/day | Matched pill placebo | Total of all reporting groups | |
Overall Number of Baseline Participants | 26 | 26 | 52 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 26 participants | 26 participants | 52 participants | |
<=18 years |
1 3.8%
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0 0.0%
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1 1.9%
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Between 18 and 65 years |
25 96.2%
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26 100.0%
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51 98.1%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 26 participants | 26 participants | 52 participants | |
34.04 (11.56) | 30.46 (11.46) | 32.25 (11.54) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 26 participants | 26 participants | 52 participants | |
Female |
14 53.8%
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12 46.2%
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26 50.0%
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Male |
12 46.2%
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14 53.8%
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26 50.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 26 participants | 26 participants | 52 participants |
26 | 26 | 52 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 sponsor shall require the PI to furnish the sponsor with a copy of any proposed publication at least 60 days prior to submission. The sponsor shall be entitled to review such proposed publications. The PI shall give due regard to the sponsor's comments on the proposed publication. If the sponsor reasonably believes a patent application claiming an invention should be filed prior to such publication, such submission shall not be submitted until applicable patent applications have been filed.
Results Point of Contact
Name/Title: | Dr. Naomi Simon |
Organization: | Massachusetts General Hospital |
Phone: | 617-726-7913 |
EMail: | nsimon@partners.org |
Responsible Party: | Naomi M. Simon, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01398514 |
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 |