Phase 4
Completed N=12
Short Course Glucocorticoid Treatment for PTSD
Source: ClinicalTrials.gov NCT00204737 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Change in Clinician-Administered PTSD Scale (CAPS) — 96.0; 90.7; 66.3; 86.2 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician-Administered PTSD Scale (CAPS) |
96.0; 90.7; 66.3; 86.2; 72.8; 81.5 | — |
| PRIMARY Number of Participants Achieving CAPS Response |
4; 0; 3; 0; 1; 0 | 0.06 |
| SECONDARY Change in Hamilton Depression Rating Scale (HAM-D) |
19.2; 16.8; 13.2; 14.8; 11.7; 14.5 | — |
| SECONDARY Change in PCL-PTSD Score |
68.7; 64.2; 58.8; 59.8; 56.0; 60.3 | — |
| SECONDARY Change in Clinical Global Impression Severity (CGI-S) Score |
5.5; 5.5; 4.7; 5.5; 4.8; 5.2 | — |
| SECONDARY Change in Dehydroepiandrosterone Sulfate (DHEA-S) |
123.8; 201.2; 87.7; 148.7; 123.5; 156.8 | — |
| SECONDARY Change in Salivary Cortisol (First 6 Participants) |
0.13; 0.08; 0.10; 0.09; 0.10; 0.07 | — |
| SECONDARY Change in Salivary Cortisol (Last 6 Participants) |
0.1; 0.138; 0.103; 0.157; 0.112; 0.183 | — |
| SECONDARY Change in Serum Glucose |
— | — |
| SECONDARY Number of Other Adverse Events |
2; 1; 3; 0; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for PTSD w/ symptom exacerbation (CAPS score ≥ 50)
- Stable on other psychotropic meds x1 month
Exclusion Criteria
- Current or past history of bipolar, schizophrenic, or other psychotic disorder
- Organic mental disorder
- Alcohol or substance abuse in last 3 months
- Clinically significant hepatic or renal disease or other acute or unstable medical condition
- Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes, rheumatologic diseases
Data sourced from ClinicalTrials.gov (NCT00204737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.