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
Recruitment status was Recruiting
Sponsor:
Sriram Ramaswamy, MD
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
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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
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 May 19, 2013