Trial Outcomes & Findings for PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims (NCT NCT02520726)

NCT ID: NCT02520726

Last Updated: 2018-04-10

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: Month
• Results posted on: 2018-04-10

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	3	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Baseline characteristics by cohort

Measure	Sertraline n=3 Participants 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.	Placebo n=2 Participants 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.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Month

Population: All subjects lost to follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: All subjects lost to follow-up

Outcome measures

Outcome data not reported

Adverse Events

Sertraline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brent Kious, MD

University of Utah

Phone: 801-585-1418

Email: brent.kious@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place