Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder in Veterans of Operation Enduring Freedom and Iraqi Freedom

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by VA Nebraska Western Iowa Health Care System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:
NCT01271244
First received: January 5, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Autonomic Reactivity
Cardiac Functioning
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF)

Resource links provided by NLM:


Further study details as provided by VA Nebraska Western Iowa Health Care System:

Primary Outcome Measures:
  • 1. To investigate the effects of escitalopram on cardiac vagal function as measured by R-R interval variability, especially in the HF (0.15-0.5 Hz) band in OEF/OIF veterans with PTSD [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • 2. To investigate the effects of escitalopram on an absolute or relative decrease in cardiac sympathetic function and serious cardiac side effects as measured by QT interval variability in OEF/OIF veterans with PTSD. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. To determine the effectiveness of escitalopram in OEF/OIF veterans with PTSD [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Veterans with Combat Related PTSD Depression Drug: Escitalopram
10-20mg daily for 12 weeks
Active Comparator: Veterans with Mjor Depression Only Drug: Escitalopram
10-20mg daily for 12 weeks

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271244

Contacts
Contact: Sriram Ramaswamy, MD 402-995-4712 sriram.ramaswamy@va.gov

Locations
United States, Nebraska
Omaha Veterans Affairs Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
Sriram Ramaswamy, MD
Forest Laboratories
Investigators
Principal Investigator: Sriram Ramaswamy, MD Department of Veterans Affairs/NWIHCS
  More Information

No publications provided

Responsible Party: Sriram Ramaswamy, MD, VA Nebraska-Western Iowa Health Care System
ClinicalTrials.gov Identifier: NCT01271244     History of Changes
Other Study ID Numbers: RAM 6-7-2008
Study First Received: January 5, 2011
Last Updated: January 5, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 22, 2014