Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Nebraska Western Iowa Health Care System
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide

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.