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

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ClinicalTrials.gov Identifier: NCT00120250
Recruitment Status : Completed
First Posted : July 15, 2005
Results First Posted : February 12, 2014
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-Traumatic Stress Disorders
Intervention Drug: Eszopiclone
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eszopiclone, Then Placebo Placebo, Then Eszopiclone
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 13 14
Completed 12 12
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             1
Protocol Violation             0             1
Arm/Group Title Drug vs Placebo
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Baseline data are unavailable for the 3 participants that did not complete the study, and therefore, the baseline data will only reflect the information of the 24 completed participants, instead of the 27 that began baseline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
19.0  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
17
  70.8%
Male
7
  29.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Short PTSD Rating Interview (SPRINT)
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.13  (4.56) 19.88  (5.47)
2.Primary Outcome
Title Pittsburgh Sleep Quality Index (PSQI)
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.30  (3.28) 11.29  (3.86)
3.Secondary Outcome
Title Sleep Latency
Hide Description Sleep Latency was derived from a subject-completed daily sleep diary.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: Minutes
25.83  (17.55) 55.83  (82.39)
4.Secondary Outcome
Title Total Sleep Time
Hide Description Total Sleep Time was derived from a subject-completed daily sleep diary.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: Minutes
390  (83.46) 362.38  (67.3)
5.Secondary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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.
Time Frame Week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.92  (17.05) 67.5  (20.83)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug vs Placebo
Hide Arm/Group Description 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.
All-Cause Mortality
Drug vs Placebo
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Drug vs Placebo
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Drug vs Placebo
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Mark Pollack
Organization: Massachusetts General Hospital
Phone: 312-942-5372
Responsible Party: Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00120250     History of Changes
Other Study ID Numbers: 2005-P-000645
First Submitted: July 7, 2005
First Posted: July 15, 2005
Results First Submitted: July 19, 2013
Results First Posted: February 12, 2014
Last Update Posted: April 26, 2016