Post-traumatic Stress Disorder
Conditions
Keywords
Posttraumatic stress disorder, PTSD, Sertraline, Burns
Brief 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).
Interventions
DRUGSertraline
\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.
DRUGPlacebo oral capsule
Matched encapsulated placebo from 1-4 capsules daily
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician-Administered PTSD Scale | Month |
Secondary
| Measure | Time frame |
|---|---|
| Beck Scale for Suicide Ideation | 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sertraline 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
Sertraline: \< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop. | 3 |
| Placebo 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.
Sertraline: \< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop. | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Sertraline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
Clinician-Administered PTSD Scale
Time frame: Month
Population: All subjects lost to follow-up
Secondary
Beck Scale for Suicide Ideation
Time frame: 1 month
Population: All subjects lost to follow-up