Stress Disorders, PosttraumaticPhase 4VSLNCT00674570
Veteran Stress and Learning Study
A Phase 4 study testing Hydrocortisone and D-Cycloserine in people with Stress Disorders, Posttraumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Posttraumatic
- What is being tested?
- Hydrocortisone and D-Cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2009to 22 Jun 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans and civilians with an age range of 18 to 65 years
- Participants must be physically healthy volunteers
Who cannot join
- Individuals who fall outside the age range
- Individuals with medical conditions that would interfere with participation
- Other criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Official title: Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.
- Conditions
- Stress Disorders, Posttraumatic
- Being tested
- Hydrocortisone, D-Cycloserine, Placebo
- Keywords
- Stress Disorders, Posttraumatic, Hydrocortisone, Cycloserine, Extinction, Psychological, PTSD, San Francisco
- 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.
HydrocortisoneDrug
25 mg/oral one hour prior to extinction task
D-CycloserineDrug
50 mg/oral one hour prior to extinction task
PlaceboDrug
One hour prior to extinction task
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Hydrocortisone | Experimental | Hydrocortisone Receives: Drug: Hydrocortisone |
| Arm 2: D-Cycloserine | Experimental | D-Cycloserine Receives: Drug: D-Cycloserine |
| Arm 3: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.
Measured: 15 minute measurement intervals on Study Days 7, 9, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study start13 Jan 2009
- Primary completion22 Jun 2015
- Study completion22 Jun 2015
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, PosttraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sabra S Inslicht, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674570
- Sponsor's protocol ID
- CDA-2-037-07F
- Other IDs
- H841-31915-01A
- Acronym
- VSL
- Status last verified
- May 2019
- First submitted
- 6 May 2008
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexandra Kredlow M, Pineles SL, Inslicht SS, Marin MF, Milad MR, Otto MW, Orr SP. Assessment of skin conductance in African American and Non-African American participants in studies of conditioned fear. Psychophysiology. 2017 Nov;54(11):1741-1754. doi: 10.1111/psyp.12909. Epub 2017 Jul 4.
PubMed 28675471Inslicht SS, Metzler TJ, Garcia NM, Pineles SL, Milad MR, Orr SP, Marmar CR, Neylan TC. Sex differences in fear conditioning in posttraumatic stress disorder. J Psychiatr Res. 2013 Jan;47(1):64-71. doi: 10.1016/j.jpsychires.2012.08.027. Epub 2012 Oct 26.
PubMed 23107307Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
PubMed 35141873
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00674570
- Acronym / sponsor ID
- VSL / CDA-2-037-07F
- Conditions
- Stress Disorders, Posttraumatic
- Keywords
- Stress Disorders, Posttraumatic, Hydrocortisone, Cycloserine, Extinction, Psychological, PTSD, San Francisco
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 13 Jan 2009 (actual)
- Primary completion
- 22 Jun 2015 (actual)
- Study completion
- 22 Jun 2015 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 30 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Hydrocortisone | Experimental | Drug: HydrocortisoneHydrocortisone |
| Arm 2: D-Cycloserine | Experimental | Drug: D-CycloserineD-Cycloserine |
| Arm 3: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans and civilians with an age range of 18 to 65 years
- Participants must be physically healthy volunteers
Key exclusion criteria (3 listed)
- Individuals who fall outside the age range
- Individuals with medical conditions that would interfere with participation
- Other criteria
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 |
|---|---|---|
| Hydrocortisone25 mg/oral one hour prior to extinction task | Drug | Arm 1: Hydrocortisone |
| D-Cycloserine50 mg/oral one hour prior to extinction task | Drug | Arm 2: D-Cycloserine |
| PlaceboOne hour prior to extinction task | Drug | Arm 3: Placebo |
Primary outcome
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Time frame: 15 minute measurement intervals on Study Days 7, 9, and 16
Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28675471Alexandra Kredlow M, Pineles SL, Inslicht SS, Marin MF, Milad MR, Otto MW, Orr SP. Assessment of skin conductance in African American and Non-African American participants in studies of conditioned fear. Psychophysiology. 2017 Nov;54(11):1741-1754. doi: 10.1111/psyp.12909. Epub 2017 Jul 4.
- Background: PubMed 23107307Inslicht SS, Metzler TJ, Garcia NM, Pineles SL, Milad MR, Orr SP, Marmar CR, Neylan TC. Sex differences in fear conditioning in posttraumatic stress disorder. J Psychiatr Res. 2013 Jan;47(1):64-71. doi: 10.1016/j.jpsychires.2012.08.027. Epub 2012 Oct 26.
- Derived from this study: PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
- Derived from this study: PubMed 35141873Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
- Individual participant dataSharing planned: No
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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.
Sabra S Inslicht, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and D-Cycloserine in people with Stress Disorders, Posttraumatic, run by VA Office of Research and Development at 1 site 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 3 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 May 2019). 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?
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS) (time frame: 15 minute measurement intervals on Study Days 7, 9, and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674570, which also lists 4 linked publications.
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 30 May 2019.