Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

• ClinicalTrials.gov Identifier: NCT01271244
• Recruitment Status: Completed
• First Posted: January 6, 2011
• Results First Posted: October 7, 2014
• Last Update Posted: May 7, 2019
• Sponsor: VA Nebraska Western Iowa Health Care System
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
PTSD	Drug: Escitalopram	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2008
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PTSD Depression Group; Escitalopram 10-20 mg/day	Drug: Escitalopram; 10-20mg daily for 12 weeks; Other Name: Lexapro
Active Comparator: Major Depression Group; Escitalopram 10-20 mg/day	Drug: Escitalopram; 10-20mg daily for 12 weeks; Other Name: Lexapro

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Locations

United States, Nebraska

Omaha Veterans Affairs Medical Center

Omaha, Nebraska, United States, 68105

Sponsors and Collaborators

VA Nebraska Western Iowa Health Care System

Forest Laboratories

Investigators

• Principal Investigator: Sriram Ramaswamy, MD; Department of Veterans Affairs/NWIHCS

More Information

• Responsible Party: Sriram Ramaswamy, Staff Psychiatrist, VA Nebraska Western Iowa Health Care System
• ClinicalTrials.gov Identifier: NCT01271244
• Other Study ID Numbers: RAM 6-7-2008
• First Posted: January 6, 2011
• Results First Posted: October 7, 2014
• Last Update Posted: May 7, 2019
• Last Verified: April 2019

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Dexetimide; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents