Trial Outcomes & Findings for A Study of Sertraline to Prevent PTSD (NCT NCT00182078)

Results Overview

The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

Baseline to Week 24

Results posted on

2014-08-05

Participant Flow

Participants and their guardians were recruited from a major pediatric burn center for an acute burn or for reconstructive surgery for a burn.

One participant withdrew consent prior to starting the study medication.

Participant milestones

Participant milestones
Measure	Placebo - Received Placebo The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.	Sertraline - Received Study Medication The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
Overall Study STARTED	9	17
Overall Study COMPLETED	8	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo - Received Placebo The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.	Sertraline - Received Study Medication The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Study of Sertraline to Prevent PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=9 Participants Placebo group who received no study medication.	Sertraline n=17 Participants Sertraline group received study medication every day for 12 weeks.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	12.4 years STANDARD_DEVIATION 3.5 • n=5 Participants	12.3 years STANDARD_DEVIATION 3.9 • n=7 Participants	12.35 years STANDARD_DEVIATION 3.71 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	17 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: Intention to treat (ITT). Analysis was conducted on participants with available data.

The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo group who received no study medication.	Sertraline n=15 Participants Sertraline group received study medication every day for 12 weeks.
Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent	-0.2 units on a scale Standard Deviation 2.6	-4.0 units on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: Intention to treat (ITT). Analysis was conducted on participants with available data.

The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo group who received no study medication.	Sertraline n=16 Participants Sertraline group received study medication every day for 12 weeks.
Diagnostic Interview for Children and Adolescents (DICA) - Child	-3.8 units on a scale Standard Deviation 3.5	-4.7 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Intention to treat (ITT). Analysis was conducted on participants with available data.

The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined.

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Placebo group who received no study medication.	Sertraline n=16 Participants Sertraline group received study medication every day for 12 weeks.
The Child Depression Inventory (CDI)	-7.5 units on a scale Standard Deviation 1.3	-2.4 units on a scale Standard Deviation 4.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sertraline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=9 participants at risk Placebo group who received no study medication.	Sertraline n=17 participants at risk Sertraline group received study medication every day for 12 weeks.
Psychiatric disorders Suicidal ideation. Tremors	0.00% 0/9	5.9% 1/17 • Number of events 1

Additional Information

Dr. Frederick J. Stoddard Jr., M.D.

Massachusetts General Hospital

Phone: 6173714762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place