Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

VA Nebraska Western Iowa Health Care System

Status and phase

Completed

Phase 4

Conditions

PTSD

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT01271244

RAM 6-7-2008

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

All

Ages

19 to 55 years old

Volunteers

No Healthy Volunteers

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.