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Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

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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:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sriram Ramaswamy, VA Nebraska Western Iowa Health Care System

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.

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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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271244


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

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Responsible Party: Sriram Ramaswamy, Staff Psychiatrist, VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier: NCT01271244     History of Changes
Other Study ID Numbers: RAM 6-7-2008
First Posted: January 6, 2011    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: May 7, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Cholinergic Antagonists
Cholinergic Agents
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
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