Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

• 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: VA Nebraska Western Iowa Health Care System
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System

Tracking Information

• First Submitted Date: January 5, 2011
• First Posted Date: January 6, 2011
• Results First Submitted Date: October 2, 2014
• Results First Posted Date: October 7, 2014
• Last Update Posted Date: May 7, 2019
• Study Start Date: June 2008
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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: Not Provided
• Original Secondary Outcome Measures (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: Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: PTSD

Intervention

Drug: Escitalopram

10-20mg daily for 12 weeks

Other Name: Lexapro

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 30, 2019): 26
• Original Estimated Enrollment (submitted: January 5, 2011): 30
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 19 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01271244
• Other Study ID Numbers: RAM 6-7-2008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System
• Study Sponsor: VA Nebraska Western Iowa Health Care System
• Collaborators: Forest Laboratories

Investigators

• Principal Investigator: Sriram Ramaswamy, MD; Department of Veterans Affairs/NWIHCS

• PRS Account: VA Nebraska Western Iowa Health Care System
• Verification Date: April 2019