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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

Tracking Information
First Submitted Date  ICMJE January 5, 2011
First Posted Date  ICMJE January 6, 2011
Results First Submitted Date  ICMJE October 2, 2014
Results First Posted Date  ICMJE October 7, 2014
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • High Frequency Heart Rate Variability [ Time Frame: 12 Weeks ]
    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.
  • QT Interval Variability [ Time Frame: 12 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
  • 1. To investigate the effects of escitalopram on cardiac vagal function as measured by R-R interval variability, especially in the HF (0.15-0.5 Hz) band in OEF/OIF veterans with PTSD [ Time Frame: 12 Weeks ]
  • 2. To investigate the effects of escitalopram on an absolute or relative decrease in cardiac sympathetic function and serious cardiac side effects as measured by QT interval variability in OEF/OIF veterans with PTSD. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01271244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
1. To determine the effectiveness of escitalopram in OEF/OIF veterans with PTSD [ Time Frame: 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
Official Title  ICMJE Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF)
Brief Summary The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.
Detailed Description The investigators are studying if taking escitalopram will normalize heart rate variability and a decrease (or no effect implying a lack of serious cardiac side effects) including QT variability in veterans with PTSD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE Drug: Escitalopram
10-20mg daily for 12 weeks
Other Name: Lexapro
Study Arms  ICMJE
  • Active Comparator: PTSD Depression Group
    Escitalopram 10-20 mg/day
    Intervention: Drug: Escitalopram
  • Active Comparator: Major Depression Group
    Escitalopram 10-20 mg/day
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2011)
30
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inclusion Criteria - Group I
  • Patients, men and women between 19 and 55 years of age, inclusive.
  • Patients with diagnosis of Posttraumatic Stress Disorder as determined by Mini-International Neuropsychiatric Interview (M.I.N.I.).
  • Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
  • Patients, who signed the written informed consent given prior to entering any study procedure.
  • Inclusion Criteria - Group II
  • Patients, men and women between 19 and 55 years of age, inclusive.
  • Patients with diagnosis of Major Depression as determined by Mini-International Neuropsychiatric Interview (M.I.N.I.). A diagnosis of PTSD will be exclusionary.
  • Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
  • Patients, who signed the written informed consent given prior to entering any study procedure.

Exclusion Criteria:

  • History of cardiovascular disease or a history of hypertension.
  • Patients with a concurrent Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis in any of the following categories as determined by the M.I.N.I.
  • Lifetime Schizophrenia and Schizoaffective Disorder
  • Lifetime Bipolar I Disorder
  • Substance Dependence or Abuse (excluding nicotine) within one month prior to the Screening Visit.
  • Patients with a history of intolerance or hypersensitivity to escitalopram or citalopram.
  • Patients who based on history or mental status examination have a significant risk of committing suicide. Current suicide risk (past month) will be assessed using the M.I.N.I. Suicidality Module. Subjects considered at high suicide risk based on the module (> 17 points) will be excluded from study participation.
  • Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
  • Subjects will be excluded who have a history of significant medical illness and who are on medications that affect cardiac and/or autonomic function.
  • Female patients who are pregnant, planning to become pregnant, or if of childbearing potential, not using an acceptable method of birth control.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01271244
Other Study ID Numbers  ICMJE RAM 6-7-2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System
Study Sponsor  ICMJE VA Nebraska Western Iowa Health Care System
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Sriram Ramaswamy, MD Department of Veterans Affairs/NWIHCS
PRS Account VA Nebraska Western Iowa Health Care System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP