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Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01271244
Recruitment Status : Completed
First Posted : January 6, 2011
Results First Posted : October 7, 2014
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition PTSD
Intervention Drug: Escitalopram
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PTSD Depression Group Major Depression Group
Hide Arm/Group Description Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
Period Title: Overall Study
Started 18 8
Completed 11 5
Not Completed 7 3
Arm/Group Title PTSD Depression Group Major Depression Group Total
Hide Arm/Group Description Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  YEARS
Number Analyzed 11 participants 5 participants 16 participants
28.3  (2.4) 30  (4.1) 29  (1.41)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
5
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
5
 100.0%
16
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 5 participants 16 participants
11 5 16
1.Primary Outcome
Title High Frequency Heart Rate Variability
Hide Description Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the small number of subjects in the major depression group, results were not analyzed for this group.
Arm/Group Title PTSD Depression Group Major Depression Group
Hide Arm/Group Description:
Veterans with PTSD and depression receive Escitalopram: 10-20mg daily for 12 weeks
Veterans with major depression receive Escitalopram: 10-20mg daily for 12 weeks
Overall Number of Participants Analyzed 11 0
Mean (Standard Deviation)
Unit of Measure: ln(msec)
Pre-treatment 6.31  (1.16)
Post-treatment 5.48  (0.67)
2.Primary Outcome
Title QT Interval Variability
Hide Description QT variability index (QTvi) is a measure of QT variability normalized to heart rate variability. Increased QTvi has been associated with increased sympathetic activity. QTvi was calculated using Berger's formula as the log ratio of QT variability normalized by the squared mean QT interval divided by heart rate variability normalized by the squared mean heart rate. QTvi is normally expressed as a negative value, and a less negative QTvi may reflect increased QT variability or reduced heart rate variability.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the small number of subjects in the major depression group, results were not analyzed for this group.
Arm/Group Title PTSD Depression Group Major Depression Group
Hide Arm/Group Description:
Veterans with PTSD and depression receive Escitalopram: 10-20mg daily for 12 weeks
Veterans with major depression receive Escitalopram: 10-20mg daily for 12 weeks
Overall Number of Participants Analyzed 11 0
Mean (Standard Deviation)
Unit of Measure: log ratio
Pre-treatment -1.82  (0.43)
Post-treatment -1.32  (0.67)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PTSD Depression Group Major Depression Group
Hide Arm/Group Description Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
All-Cause Mortality
PTSD Depression Group Major Depression Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PTSD Depression Group Major Depression Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   1/8 (12.50%) 
Psychiatric disorders     
Suicidal Ideation *  0/18 (0.00%)  1/8 (12.50%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PTSD Depression Group Major Depression Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/8 (0.00%) 
Due to small number of subjects recruited in major depression group we are unable to compare to the PTSD group.
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
Layout table for Results Point of Contact information
Name/Title: SRIRAM RAMASWAMY MD
Organization: VA NEBRASKA WESTERN IOWA VA HEALTHCARE
Phone: 4029954712
EMail: SRIRAM.RAMASWAMY@VA.GOV
Layout table for additonal information
Responsible Party: Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier: NCT01271244     History of Changes
Other Study ID Numbers: RAM 6-7-2008
First Submitted: January 5, 2011
First Posted: January 6, 2011
Results First Submitted: October 2, 2014
Results First Posted: October 7, 2014
Last Update Posted: May 7, 2019