Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271244
• Other study ID #: RAM 6-7-2008
• Status: Completed
• Phase: Phase 4
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: April 2019
• Source: VA Nebraska Western Iowa Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Escitalopram
10-20mg daily for 12 weeks

Locations

Country	Name	City	State
United States	Omaha Veterans Affairs Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
VA Nebraska Western Iowa Health Care System	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Frequency Heart Rate Variability	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.	12 Weeks
Primary	QT Interval Variability	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.	12 weeks