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The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone in addition to standard care will result in reduced PTSD symptoms or symptom severity compared to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Active Comparator | Prednisone 20mg daily x 2 weeks |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone | Drug | 20mg x 2 weeks |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician-Administered PTSD Scale (CAPS) | This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms. | baseline, 2 weeks, 6 weeks, 12 weeks |
| Number of Participants Achieving CAPS Response | CAPS response defined as a 30% reduction in CAPS score from baseline. | baseline, 2 weeks, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HAM-D) | HAM-D is a 21-item survey where scoring is based on the first 17-items. It has a total possible range of scores 0-50 where higher scores indicate more severe depression. | baseline, 2 weeks, 6 weeks, 12 weeks |
| Change in PCL-PTSD Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine D. Johnson, PharmD, MS, BCPP | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catherine Johnson | Madison | Wisconsin | 53711 | United States | ||
| Wm. S. Middleton VA Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks |
| FG001 | Placebo | placebo placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks |
| BG001 | Placebo | placebo placebo: placebo |
| 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 | Change in Clinician-Administered PTSD Scale (CAPS) | This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 weeks, 6 weeks, 12 weeks |
|
up to 3 weeks
There is no longer access to total participants affected by Other Adverse Events, therefore we report 0 participants affected and at risk in this table. Please refer to Outcome Measure 10 where the available Other Adverse Event information for this study is reported.
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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 | Prednisone | Prednisone 20mg daily x 2 weeks prednisone: 20mg x 2 weeks | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Johnson | University of Wisconsin - Madison | 608-280-7084 | catherine.johnson2@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 |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
placebo |
|
PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms. |
| baseline, 2 weeks, 6 weeks, 12 weeks |
| Change in Clinical Global Impression Severity (CGI-S) Score | CGI-S is scored by a clinician. It is a 7 point scale where 1 = normal, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. | baseline, 2 weeks, 6 weeks, 12 weeks |
| Change in Dehydroepiandrosterone Sulfate (DHEA-S) | DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks | Baseline, 2 weeks, 6 weeks, and 12 weeks |
| Change in Salivary Cortisol (First 6 Participants) | Baseline, 2 weeks, 6 weeks, and 12 weeks |
| Change in Salivary Cortisol (Last 6 Participants) | Participants provided saliva samples at 16:00, 24:00, and 08:00. After these samples are collected, participants take 0.5mg dexamethasone orally at 23:00, and a fourth sample is collected at 08:00 post dexamethasone. Post-dexamethasone data is reported here. | Baseline, 2 weeks, 6 weeks, and 12 weeks |
| Change in Serum Glucose | Baseline, 2 weeks, 6 weeks, and 12 weeks |
| Number of Other Adverse Events | The Systematic Assessment for Treatment Emergent Events-General Inquiry (SAFTEE-GI) was used to collect and analyze data about potential medication related side effects. Each of 12 subjects was queried using the SAFTEE-GI at 3 time points (1, 2 and 3 weeks) for a possible of 36 adverse event reports. | up to 3 weeks |
| Madison |
| Wisconsin |
| 53711 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Trauma Type | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Percent Service Connection | Disability compensation is a monetary benefit paid to Veterans determined by the VA to be disabled by an injury or illness that was incurred or aggravated during active military service. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Achieving CAPS Response | CAPS response defined as a 30% reduction in CAPS score from baseline. | Posted | Count of Participants | Participants | baseline, 2 weeks, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Change in Hamilton Depression Rating Scale (HAM-D) | HAM-D is a 21-item survey where scoring is based on the first 17-items. It has a total possible range of scores 0-50 where higher scores indicate more severe depression. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 weeks, 6 weeks, 12 weeks |
|
|
|
| Secondary | Change in PCL-PTSD Score | PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 weeks, 6 weeks, 12 weeks |
|
|
|
| Secondary | Change in Clinical Global Impression Severity (CGI-S) Score | CGI-S is scored by a clinician. It is a 7 point scale where 1 = normal, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 weeks, 6 weeks, 12 weeks |
|
|
|
| Secondary | Change in Dehydroepiandrosterone Sulfate (DHEA-S) | DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks | Posted | Mean | Standard Deviation | mcg/dl | Baseline, 2 weeks, 6 weeks, and 12 weeks |
|
|
|
| Secondary | Change in Salivary Cortisol (First 6 Participants) | Midway through the study, the protocol related to salivary cortisol was modified to add the dexamethasone suppression test to better understand response of the hypothalamic pituitary adrenal (HPA) axis to a steroid challenge. This is why no participants were analyzed during week 2. | Posted | Mean | Standard Deviation | ug/dl | Baseline, 2 weeks, 6 weeks, and 12 weeks |
|
|
|
| Secondary | Change in Salivary Cortisol (Last 6 Participants) | Participants provided saliva samples at 16:00, 24:00, and 08:00. After these samples are collected, participants take 0.5mg dexamethasone orally at 23:00, and a fourth sample is collected at 08:00 post dexamethasone. Post-dexamethasone data is reported here. | One participant in the Prednisone arm did not provide enough sample for analysis and one additional participant in the Prednisone arm did not provide enough sample for analysis at week 6. Data was not collected for week 2 due to protocol amendment to change cortisol testing. | Posted | Mean | Standard Deviation | ug/dl | Baseline, 2 weeks, 6 weeks, and 12 weeks |
|
|
|
| Secondary | Change in Serum Glucose | Data no longer exists in the research file depository due it its vintage. Unable to report this measure. | Posted | Baseline, 2 weeks, 6 weeks, and 12 weeks |
|
|
| Secondary | Number of Other Adverse Events | The Systematic Assessment for Treatment Emergent Events-General Inquiry (SAFTEE-GI) was used to collect and analyze data about potential medication related side effects. Each of 12 subjects was queried using the SAFTEE-GI at 3 time points (1, 2 and 3 weeks) for a possible of 36 adverse event reports. | Posted | Number | incidence of adverse events | up to 3 weeks |
|
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 0 |
| EG001 | Placebo | placebo placebo: placebo | 0 | 6 | 0 | 6 | 0 | 0 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| baseline to 12 weeks |
|
| 0.18 |
| Other |
| Comparison at 12 weeks | Fisher Exact | 0.5 | Other |
| 6 Weeks |
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| 12 Weeks |
|
| 6 Weeks |
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| 12 Weeks |
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| 6 Weeks |
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| 12 Weeks |
|
| 6 Weeks |
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| 12 Weeks |
|
| 2 Weeks |
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| 6 Weeks |
|
|
| 12 Weeks |
|
|
| 2 Weeks |
|
| 6 Weeks |
|
|
| 12 Weeks |
|
|
| Reduced Blood Sugar |
|
| Decreased Energy |
|
| Upper Respiratory Infection |
|
| Increased Mood |
|
| Mild Urinary Hesitancy |
|