Conditions: Post-traumatic Stress Disorder
Keywords: Posttraumatic stress disorder PTSD Sertraline Burns
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: 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 arm 2: 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.

Interventions: intervention 1: Sertraline intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: \< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop. intervention 2: Matched encapsulated placebo from 1-4 capsules daily

Protocol document: