PTSD
Conditions
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.
Interventions
DRUGEscitalopram
10-20mg daily for 12 weeks
Sponsors
Forest Laboratories
VA Nebraska Western Iowa Health Care System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Frequency Heart Rate Variability | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PTSD Depression Group Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks | 11 |
| Major Depression Group Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks | 5 |
| Total | 16 |
Baseline characteristics
| Characteristic | PTSD Depression Group | Major Depression Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 5 Participants | 16 Participants |
| Age, Continuous | 28.3 YEARS STANDARD_DEVIATION 2.4 | 30 YEARS STANDARD_DEVIATION 4.1 | 29 YEARS STANDARD_DEVIATION 1.41 |
| Region of Enrollment United States | 11 participants | 5 participants | 16 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 8 |
| serious Total, serious adverse events | 0 / 18 | 1 / 8 |
Outcome results
Primary
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.
Time frame: 12 Weeks
Population: Due to the small number of subjects in the major depression group, results were not analyzed for this group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Depression Group | High Frequency Heart Rate Variability | Pre-treatment | 6.31 ln(msec) | Standard Deviation 1.16 |
| PTSD Depression Group | High Frequency Heart Rate Variability | Post-treatment | 5.48 ln(msec) | Standard Deviation 0.67 |
Primary
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.
Time frame: 12 weeks
Population: Due to the small number of subjects in the major depression group, results were not analyzed for this group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Depression Group | QT Interval Variability | Pre-treatment | -1.82 log ratio | Standard Deviation 0.43 |
| PTSD Depression Group | QT Interval Variability | Post-treatment | -1.32 log ratio | Standard Deviation 0.67 |