Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

Condition(s) targeted: PTSD

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: VA Nebraska Western Iowa Health Care System

Official(s) and/or principal investigator(s):
Sriram Ramaswamy, MD, Principal Investigator, Affiliation: Department of Veterans Affairs/NWIHCS

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

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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.

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.

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.

Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Both.

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 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 MINI 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.

Omaha Veterans Affairs Medical Center, Omaha, Nebraska 68105, United States

Starting date: June 2008
Last updated: October 2, 2014