Back to resultsEffects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
Primary Purpose
PTSD
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for PTSD
Eligibility 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.
Sites / Locations
- Omaha Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PTSD Depression Group
Major Depression Group
Arm Description
Escitalopram 10-20 mg/day
Escitalopram 10-20 mg/day
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01271244
First Posted
January 5, 2011
Last Updated
April 30, 2019
Sponsor
VA Nebraska Western Iowa Health Care System
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01271244
Brief Title
Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Nebraska Western Iowa Health Care System
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTSD Depression Group
Arm Type
Active Comparator
Arm Description
Escitalopram 10-20 mg/day
Arm Title
Major Depression Group
Arm Type
Active Comparator
Arm Description
Escitalopram 10-20 mg/day
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10-20mg daily for 12 weeks
Primary Outcome Measure Information:
Title
High Frequency Heart Rate Variability
Description
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.
Time Frame
12 Weeks
Title
QT Interval Variability
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Ramaswamy, MD
Organizational Affiliation
Department of Veterans Affairs/NWIHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omaha Veterans Affairs Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
12. IPD Sharing Statement
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Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
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