Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

NCT ID: NCT01271244

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-06-30

Brief Summary

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

Detailed Description

The investigators 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.

Conditions

PTSD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTSD Depression Group

Escitalopram 10-20 mg/day

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

10-20mg daily for 12 weeks

Major Depression Group

Escitalopram 10-20 mg/day

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

10-20mg daily for 12 weeks

Interventions

Escitalopram

10-20mg daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Lexapro

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

VA Nebraska Western Iowa Health Care System

FED

Sponsor Role: lead

Responsible Party

Sriram Ramaswamy

Staff Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sriram Ramaswamy, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Veterans Affairs/NWIHCS

Locations

Omaha Veterans Affairs Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

RAM 6-7-2008

Identifier Type: -

Identifier Source: org_study_id