Trial Outcomes & Findings for Suvorexant and Trauma Related Insomnia (NCT NCT02704754)
NCT ID: NCT02704754
Last Updated: 2023-02-15
Results Overview
A seven-item measure used to evaluate insomnia severity for the preceding two weeks. Items are scored on a 5-point scale and a total score ranging between 0 and 28 is obtained by summing the seven items, with higher scores indicating greater insomnia severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Baseline score minus 6 weeks or last observation (measure was also obtained at 2 and 4 weeks, the mathematical mean for the "last observation" was 5 weeks).
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
Suvorexant
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Suvorexant
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Suvorexant and Trauma Related Insomnia
Baseline characteristics by cohort
| Measure |
Suvorexant
n=18 Participants
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=19 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
Total
n=37 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
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 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
|
35.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Clinician Assessed PTSD Scale for DSM5 (CAPS-5)
|
8.8 units on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 7.1 • n=7 Participants
|
9.38 units on a scale
STANDARD_DEVIATION 7.76 • n=5 Participants
|
|
Insomnia Severity Index
|
14.9 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 4.8 • n=7 Participants
|
15.07 units on a scale
STANDARD_DEVIATION 4.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline score minus 6 weeks or last observation (measure was also obtained at 2 and 4 weeks, the mathematical mean for the "last observation" was 5 weeks).A seven-item measure used to evaluate insomnia severity for the preceding two weeks. Items are scored on a 5-point scale and a total score ranging between 0 and 28 is obtained by summing the seven items, with higher scores indicating greater insomnia severity.
Outcome measures
| Measure |
Suvorexant
n=18 Participants
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=19 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Change in Insomnia Severity Index Score From Baseline.
|
6.8 units on a scale
Standard Deviation 5.0
|
8.6 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline score minus 6 weeks or last observation (measure was also obtained at 2 and 4 weeks, the mathematical mean for the "last observation" was 5 weeks).Evaluates the frequency and intensity of each of the diagnostic symptoms of PTSD including nightmares and insomnia, total score was used which is a summation of all item scores, scores range between 0 to 80 with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Suvorexant
n=18 Participants
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=19 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Change in Clinician Administered PTSD Scale Score
|
4.2 units on a scale
Standard Deviation 6.3
|
3.8 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline values minus the values at 2 weeks.Population: There were 5 patients in the suvorexant group and 6 in the placebo group who provided clinical ratings but for whom the second polysomnography was missed due to scheduling or was not scorable due to technical problems.
Polysomnography will provide objective measures of sleep, wake after sleep onset is the amount of wake time that occurs after initially falling asleep to the final awakening for the total sleep period measured in minutes.
Outcome measures
| Measure |
Suvorexant
n=13 Participants
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=13 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Polysomnographically Measured Wake After Sleep Onset
|
21.0 minutes
Standard Deviation 16.6
|
22.3 minutes
Standard Deviation 11.6
|
Adverse Events
Suvorexant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suvorexant
n=18 participants at risk
10 to 20 mg to be administered before bedtime
suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=19 participants at risk
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Nervous system disorders
sedation
|
5.6%
1/18 • Number of events 1 • Weeks 1, 2, 4, and 6 of medication treatment and 1-week following end of medication treatment
|
0.00%
0/19 • Weeks 1, 2, 4, and 6 of medication treatment and 1-week following end of medication treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place