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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD Depression Group | Active Comparator | Escitalopram 10-20 mg/day |
|
| Major Depression Group | Active Comparator | Escitalopram 10-20 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10-20mg daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriram Ramaswamy, MD | Department of Veterans Affairs/NWIHCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omaha Veterans Affairs Medical Center | Omaha | Nebraska | 68105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PTSD Depression Group | Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks |
| FG001 | Major Depression Group | Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PTSD Depression Group | Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks |
| BG001 | Major Depression Group | Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Due to the small number of subjects in the major depression group, results were not analyzed for this group. | Posted | Mean | Standard Deviation | ln(msec) | 12 Weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTSD Depression Group | Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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Due to small number of subjects recruited in major depression group we are unable to compare to the PTSD group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SRIRAM RAMASWAMY MD | VA NEBRASKA WESTERN IOWA VA HEALTHCARE | 4029954712 | SRIRAM.RAMASWAMY@VA.GOV |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Veterans with major depression receive Escitalopram: 10-20mg daily for 12 weeks |
|
|
| 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. | Due to the small number of subjects in the major depression group, results were not analyzed for this group. | Posted | Mean | Standard Deviation | log ratio | 12 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Major Depression Group | Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks | 1 | 8 | 0 | 8 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |