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Completed

NCT Number: NCT01271244

Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Omaha Veterans Affairs Medical Center

Omaha, Nebraska, 68105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

10-20mg daily for 12 weeks

Other names: Lexapro

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

VA Nebraska Western Iowa Health Care System

Fed

Collaborators

  • Forest Laboratories

Registry information

Official study title

Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF)

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2011
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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