Clinical trial NCT01271244: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: PTSD
Lead sponsor: VA Nebraska Western Iowa Health Care System
Sponsor class: FED
Collaborators: name: Forest Laboratories
First posted: 2011-01-06
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: High Frequency Heart Rate Variability
timeFrame: 12 Weeks
measure: QT Interval Variability
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Omaha Veterans Affairs Medical Center
state: Nebraska
Study officials:
affiliation: Department of Veterans Affairs/NWIHCS
name: Sriram Ramaswamy, MD
role: PRINCIPAL_INVESTIGATOR
References: