Post-traumatic Stress DisorderPhase 4NCT02520726
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
A Phase 4 study testing Sertraline in people with Post-traumatic Stress Disorder, run by University of Utah at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD). 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?
- Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2016
- 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
- Victim of a traumatic event leading to personal injury
- Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward
- Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.
Who cannot join
- Age < 18
- Pregnant women, lactating women, or women not using acceptable form of birth control
- Epilepsy or head trauma resulting in seizures
- Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior
- Current/previously diagnosed PTSD
- History of hypersensitivity to sertraline
Show all 12Show fewer
- Trauma occurring > 7 days prior to likely first treatment in the randomization phase of the trial.
- Unable to provide informed consent for participation in the study protocol.
- Patient at high risk of recurrent bleeding despite surgical stabilization
- Patient with a history of serotonin syndrome
- Patient non-fluent in English
- Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI, mirtazapine, or trazodone in excess of 100mg per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims
This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Sertraline, Placebo oral capsule
- Keywords
- Posttraumatic stress disorder, PTSD, Sertraline, Burns
- Medical subject headings
- Stress Disorders, Post-Traumatic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.
Placebo oral capsuleDrug
Matched encapsulated placebo from 1-4 capsules daily
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration Receives: Drug: Sertraline |
| Placebo | Placebo comparator | Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale
Measured: Month
Secondary outcomes (1)
Beck Scale for Suicide Ideation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Insufficient enrollment
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 UtahThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Kious, University of Utah
- Investigators
- Brent M Kious, MD PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520726
- Sponsor's protocol ID
- UUtahIRB0062412
- Status last verified
- Dec 2017
- First submitted
- 18 Apr 2014
- Last updated
- 10 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims
- ClinicalTrials.gov ID
- NCT02520726
- Acronym / sponsor ID
- UUtahIRB0062412
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Posttraumatic stress disorder, PTSD, Sertraline, Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 10 Apr 2018
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 randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: SertralinePatients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Victim of a traumatic event leading to personal injury
- Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward
- Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.
Key exclusion criteria (12 listed)
- Age < 18
- Pregnant women, lactating women, or women not using acceptable form of birth control
- Epilepsy or head trauma resulting in seizures
- Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior
- Current/previously diagnosed PTSD
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 |
|---|---|---|
| SertralineAlso: Zoloft< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop. | Drug | Sertraline |
| Placebo oral capsuleMatched encapsulated placebo from 1-4 capsules daily | Drug | Placebo |
Primary outcome
Clinician-Administered PTSD Scale
Time frame: Month
1 secondary outcome
Beck Scale for Suicide Ideation
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- 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.
Brent M Kious, MD PhD principal investigator
University of Utah
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 Sertraline in people with Post-traumatic Stress Disorder, run by University of Utah 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Apr 2018. 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 10 Apr 2018). 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?
Clinician-Administered PTSD Scale (time frame: Month). 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 10 Apr 2018.