Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Escitalopram
Intervention description: 10-20mg daily for 12 weeks
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The study looked at relationship between escitalopram and heart rate variability and 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.