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Phase 4 N=26 Treatment

Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

PTSD

Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Oct 2014
Primary outcome: Primary: High Frequency Heart Rate Variability — 6.31; 5.48 ln(msec)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Escitalopram (Drug)
Age
Adult · 19+ yrs
Sex
All
Sponsor
VA Nebraska Western Iowa Health Care System
Primary completion
Jun 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
High Frequency Heart Rate Variability
6.31; 5.48
PRIMARY
QT Interval Variability
-1.82; -1.32

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01271244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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