Trial Outcomes & Findings for Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder (NCT NCT00120250)

Results Overview

The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Eszopiclone, Then Placebo The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.	Placebo, Then Eszopiclone The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
Overall Study STARTED	13	14
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Eszopiclone, Then Placebo The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.	Placebo, Then Eszopiclone The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug vs Placebo n=24 Participants Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	19.0 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Eszopiclone n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.	Placebo n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Short PTSD Rating Interview (SPRINT)	16.13 units on a scale Standard Deviation 4.56	19.88 units on a scale Standard Deviation 5.47

PRIMARY outcome

Timeframe: 8 weeks

The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.

Outcome measures

Outcome measures
Measure	Eszopiclone n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.	Placebo n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Pittsburgh Sleep Quality Index (PSQI)	8.30 units on a scale Standard Deviation 3.28	11.29 units on a scale Standard Deviation 3.86

SECONDARY outcome

Timeframe: 8 weeks

Sleep Latency was derived from a subject-completed daily sleep diary.

Outcome measures

Outcome measures
Measure	Eszopiclone n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.	Placebo n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Sleep Latency	25.83 Minutes Standard Deviation 17.55	55.83 Minutes Standard Deviation 82.39

SECONDARY outcome

Timeframe: 8 weeks

Total Sleep Time was derived from a subject-completed daily sleep diary.

Outcome measures

Outcome measures
Measure	Eszopiclone n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.	Placebo n=24 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Total Sleep Time	390 Minutes Standard Deviation 83.46	362.38 Minutes Standard Deviation 67.3

SECONDARY outcome

Timeframe: Week 3

The CAPS is a highly detailed measure of the presence and severity of the DSM-IV PTSD criteria. The severity score was calculated by adding up the frequency score (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score (scale 0 = "none" to 4 = "extreme"), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology. In this case, the total score for all 17 symptom questions, which is also the sum of the three symptom clusters, is used.

Outcome measures

Outcome measures
Measure	Eszopiclone n=12 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.	Placebo n=12 Participants The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Clinician-Administered PTSD Scale (CAPS)	53.92 units on a scale Standard Deviation 17.05	67.5 units on a scale Standard Deviation 20.83

Adverse Events

Drug vs 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

Dr. Mark Pollack

Massachusetts General Hospital

Phone: 312-942-5372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place