PTSDPhase 4NCT01271244

Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

A Phase 4 study testing Escitalopram in people with PTSD, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 19 to 55 years
Conditions the study is for: PTSD
What is being tested?: Escitalopram
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Jun 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Omaha Veterans Affairs Medical Center
Omaha, Nebraska, 68105

Other trials in United States

About this study

Official title: Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF)

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

Read the 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
Being tested: Escitalopram
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EscitalopramDrug
Also called Lexapro
10-20mg daily for 12 weeks

Study groups in NCT01271244
Study group	Role	What they receive
PTSD Depression Group	Active comparator	Escitalopram 10-20 mg/day Receives: Drug: Escitalopram
Major Depression Group	Active comparator	Escitalopram 10-20 mg/day Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

High Frequency Heart Rate Variability
Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure.
Measured: 12 Weeks
QT Interval Variability
QT variability index (QTvi) is a measure of QT variability normalized to heart rate variability. Increased QTvi has been associated with increased sympathetic activity. QTvi was calculated using Berger's formula as the log ratio of QT variability normalized by the squared mean QT interval divided by heart rate variability normalized by the squared mean heart rate. QTvi is normally expressed as a negative value, and a less negative QTvi may reflect increased QT variability or reduced heart rate variability.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jun 2013

First posted6 Jan 2011 (estimated)
Study startJun 2008
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PTSDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01271244
Sponsor's protocol ID: RAM 6-7-2008
Status last verified: Apr 2019
First submitted: 5 Jan 2011
Last updated: 7 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF)
ClinicalTrials.gov ID: NCT01271244
Acronym / sponsor ID: RAM 6-7-2008
Conditions: PTSD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: VA Nebraska Western Iowa Health Care SystemUS federal agency
Collaborators: Forest Laboratories
Study start: Jun 2008
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 6 Jan 2011 (estimated)
Results: Posted 7 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PTSD Depression Group	Active comparator	Drug: EscitalopramEscitalopram 10-20 mg/day
Major Depression Group	Active comparator	Drug: EscitalopramEscitalopram 10-20 mg/day

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EscitalopramAlso: Lexapro10-20mg daily for 12 weeks	Drug	Major Depression Group, PTSD Depression Group

Primary outcome

High Frequency Heart Rate Variability
Time frame: 12 Weeks
Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure.
QT Interval Variability
Time frame: 12 weeks
QT variability index (QTvi) is a measure of QT variability normalized to heart rate variability. Increased QTvi has been associated with increased sympathetic activity. QTvi was calculated using Berger's formula as the log ratio of QT variability normalized by the squared mean QT interval divided by heart rate variability normalized by the squared mean heart rate. QTvi is normally expressed as a negative value, and a less negative QTvi may reflect increased QT variability or reduced heart rate variability.

Results and safety

Results posted to the registry on 7 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PTSD Depression Group	18	11
Major Depression Group	8	5

Primary outcome: High Frequency Heart Rate Variability

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: ln(msec)

Measure	PTSD Depression Group n = 11	Major Depression Group n = 0
Pre-treatment	6.31 (1.16)	–
Post-treatment	5.48 (0.67)	–

Population analysed: Due to the small number of subjects in the major depression group, results were not analyzed for this group.

Primary outcome: QT Interval Variability

Time frame: 12 weeks. Mean (Standard Deviation). Unit: log ratio

Measure	PTSD Depression Group n = 11	Major Depression Group n = 0
Pre-treatment	-1.82 (0.43)	–
Post-treatment	-1.32 (0.67)	–

Population analysed: Due to the small number of subjects in the major depression group, results were not analyzed for this group.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PTSD Depression Group	0 of 18 (0%)	0 of 18 (0%)	Not reported
Major Depression Group	1 of 8 (12.5%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): Due to small number of subjects recruited in major depression group we are unable to compare to the PTSD group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sriram Ramaswamy, MD principal investigator

Department of Veterans Affairs/NWIHCS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram in people with PTSD, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

High Frequency Heart Rate Variability (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01271244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.