Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder in Veterans of Operation Enduring Freedom and Iraqi Freedom
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Psychiatric |
Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 19 - 55 |
Updated: | 11/8/2014 |
Start Date: | June 2008 |
Contact: | Sriram Ramaswamy, MD |
Email: | sriram.ramaswamy@va.gov |
Phone: | 402-995-4712 |
Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF)
We 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
(or no effect implying a lack of serious cardiac side effects) including QT variability in
veterans with PTSD
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 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 MINI
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.
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