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

History of Changes

Results First Received: July 25, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (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.
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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

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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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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 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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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
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
Study First Received:	July 12, 2011
Results First Received:	July 25, 2013
Last Updated:	June 5, 2014

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