Post-traumatic Stress DisorderPhase 4NCT00204737
Short Course Glucocorticoid Treatment for PTSD
A Phase 4 study testing prednisone in people with Post-traumatic Stress Disorder, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2004to Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Catherine Johnson
Madison, Wisconsin, 53711
Wm. S. Middleton VA Hospital
Madison, Wisconsin, 53711
About this study
Official title: A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
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
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- prednisone, placebo
- 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.
prednisoneDrug
20mg x 2 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Prednisone 20mg daily x 2 weeks Receives: Drug: prednisone |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 2 weeks, 6 weeks, 12 weeks
Secondary outcomes (8)
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.
Measured: baseline, 2 weeks, 6 weeks, 12 weeks
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.
Measured: 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.
Measured: 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
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks
Change in Salivary Cortisol (First 6 Participants)
Measured: 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.
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks
Change in Serum Glucose
Measured: 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.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJan 2009
- Study completionJan 2009
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 Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine D. Johnson, PharmD, MS, BCPP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204737
- Sponsor's protocol ID
- H-2004-0039
- Status last verified
- Apr 2020
- First submitted
- 12 Sep 2005
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00204737
- Acronym / sponsor ID
- H-2004-0039
- Conditions
- Post-traumatic Stress Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 6 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: prednisonePrednisone 20mg daily x 2 weeks |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| prednisone20mg x 2 weeks | Drug | Prednisone |
| placeboplacebo | Drug | placebo |
Primary outcome
Change in Clinician-Administered PTSD Scale (CAPS)
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks
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.
Number of Participants Achieving CAPS Response
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks
CAPS response defined as a 30% reduction in CAPS score from baseline.
8 secondary outcomes
Change in Hamilton Depression Rating Scale (HAM-D)
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks
Change in PCL-PTSD Score
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks
Change in Clinical Global Impression Severity (CGI-S) Score
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks
Change in Salivary Cortisol (First 6 Participants)
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks
Change in Salivary Cortisol (Last 6 Participants)
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks
Change in Serum Glucose
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks
Number of Other Adverse Events
Time frame: up to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- 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.
Catherine D. Johnson, PharmD, MS, BCPP principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prednisone in people with Post-traumatic Stress Disorder, run by University of Wisconsin, Madison at 2 sites 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 2 inclusion and 5 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 6 May 2020). 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?
Change in Clinician-Administered PTSD Scale (CAPS) (time frame: baseline, 2 weeks, 6 weeks, 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?
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 6 May 2020.