Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

NCT01271244 | Completed Phase 4 Results

• 1 other identifier: RAM 6-7-2008
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PTSD

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

PTSD Depression Group

ACTIVE COMPARATOR

Escitalopram 10-20 mg/day

Drug: Escitalopram

Major Depression Group

ACTIVE COMPARATOR

Escitalopram 10-20 mg/day

Drug: Escitalopram

Interventions

Escitalopram DRUG

10-20mg daily for 12 weeks

Also known as: Lexapro

Major Depression Group; PTSD Depression Group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patients, men and women between 19 and 55 years of age, inclusive.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Nebraska Western Iowa Health Care System: lead
• Forest Laboratories: collaborator

Study Sites (1)

Omaha Veterans Affairs Medical Center

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to small number of subjects recruited in major depression group we are unable to compare to the PTSD group.

Results Point of Contact

• Title: SRIRAM RAMASWAMY MD
• Organization: VA NEBRASKA WESTERN IOWA VA HEALTHCARE

SRIRAM.RAMASWAMY@VA.GOV

4029954712

Study Officials

• Sriram Ramaswamy, MD

  Department of Veterans Affairs/NWIHCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 7, 2019
• Results First Posted: October 7, 2014

Record last verified: 2019-04

Locations

US (1)