Trial Outcomes & Findings for Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder (NCT NCT02849548)
NCT ID: NCT02849548
Last Updated: 2023-06-02
Results Overview
A structured clinical interview used to assess posttraumatic stress disorder (PTSD) symptom severity for the preceding week. Items are scored on a 5-point scale, and a total score is obtained by summing the 20 symptom items, with higher scores indicating greater PTSD symptom severity. The total scores range from 0 - 80.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-06-02
Participant Flow
Participant milestones
| Measure |
Suvorexant
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
|
Placebo Pill
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Suvorexant
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist 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
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Suvorexant
n=13 Participants
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=14 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
Total
n=27 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
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 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
|
31 years
STANDARD_DEVIATION 8 • n=5 Participants
|
35 years
STANDARD_DEVIATION 10 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
1-week Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
|
23.2 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
28.0 units on a scale
STANDARD_DEVIATION 12.4 • n=7 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Baseline-corrected highest SUDS at the 1st written narrative exposure session
|
32.0 units on a scale
STANDARD_DEVIATION 18.4 • n=5 Participants
|
35.3 units on a scale
STANDARD_DEVIATION 18.3 • n=7 Participants
|
33.7 units on a scale
STANDARD_DEVIATION 18.1 • n=5 Participants
|
|
Baseline-corrected highest 2-min average pulse rate at the 1st written narrative exposure session
|
5.9 beats per minute
STANDARD_DEVIATION 4.6 • n=5 Participants
|
7.2 beats per minute
STANDARD_DEVIATION 5.9 • n=7 Participants
|
6.6 beats per minute
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksA structured clinical interview used to assess posttraumatic stress disorder (PTSD) symptom severity for the preceding week. Items are scored on a 5-point scale, and a total score is obtained by summing the 20 symptom items, with higher scores indicating greater PTSD symptom severity. The total scores range from 0 - 80.
Outcome measures
| Measure |
Suvorexant
n=11 Participants
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=12 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score at Week 2
|
16.6 score on a scale
Standard Deviation 7.3
|
17.1 score on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 1 weekThe subjective unit of distress scale (SUDS) is a numerical scale that is administered orally. It ranges from 0 - 100 in which 0 indicates no stress at all, and 100 indicates the highest stress level. The highest SUDS score for each session was identified and corrected for the baseline SUDS of the session by subtracting the baseline SUDS from the SUDS within the session; therefore, the baseline-corrected SUDS scores can range from 0 to 100.
Outcome measures
| Measure |
Suvorexant
n=11 Participants
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=12 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
The Baseline-corrected Highest Subjective Unit of Distress Scale (SUDS) Scores at the Last Written Narrative Exposure Session
|
18.9 score on a scale
Standard Deviation 15.8
|
40.3 score on a scale
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: 1weekThe average pulse rate for a 5-minute baseline and each 2-minute epoch during 30-min written narrative exposure were computed. The highest average pulse rate for each session was identified and corrected for the baseline pulse rate of the session by subtracting the baseline average pulse rate from the highest average pulse rate within the session. The Baseline-corrected highest pulse rate values reported here are small because the baseline average pulse rate of the session was subtracted from the highest 2-minute average pulse rate of the session.
Outcome measures
| Measure |
Suvorexant
n=11 Participants
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=12 Participants
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
The Baseline-corrected Highest Pulse Rate Across at the Last Written Narrative Exposure Session
|
5.3 beats per minute
Standard Deviation 3.0
|
4.8 beats per minute
Standard Deviation 2.4
|
Adverse Events
Suvorexant
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Pill
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suvorexant
n=13 participants at risk
10 to 20 mg to be administered after an evening written trauma narrative exposure session.
suvorexant: First in class orexin antagonist approved by the FDA for the treatment of insomnia
|
Placebo Pill
n=14 participants at risk
A pill without active ingredients
placebo: Pill with inactive ingredients
|
|---|---|---|
|
General disorders
Fatigue
|
30.8%
4/13 • 2 weeks
Interview with open-ended questions.
|
21.4%
3/14 • 2 weeks
Interview with open-ended questions.
|
|
Nervous system disorders
Somnolence
|
23.1%
3/13 • 2 weeks
Interview with open-ended questions.
|
14.3%
2/14 • 2 weeks
Interview with open-ended questions.
|
|
Nervous system disorders
Depression
|
15.4%
2/13 • 2 weeks
Interview with open-ended questions.
|
7.1%
1/14 • 2 weeks
Interview with open-ended questions.
|
|
Nervous system disorders
Anxiety
|
7.7%
1/13 • 2 weeks
Interview with open-ended questions.
|
14.3%
2/14 • 2 weeks
Interview with open-ended questions.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • 2 weeks
Interview with open-ended questions.
|
14.3%
2/14 • 2 weeks
Interview with open-ended questions.
|
|
Nervous system disorders
Nightmare
|
15.4%
2/13 • 2 weeks
Interview with open-ended questions.
|
0.00%
0/14 • 2 weeks
Interview with open-ended questions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place