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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00120250
First received: July 7, 2005
Last updated: December 26, 2013
Last verified: December 2013
Results First Received: July 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Post-Traumatic Stress Disorders
Intervention: Drug: Eszopiclone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Eszopiclone, Then Placebo     Placebo, Then Eszopiclone  
STARTED     13     14  
COMPLETED     12     12  
NOT COMPLETED     1     2  
Lost to Follow-up                 1                 1  
Protocol Violation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Drug vs Placebo 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.

Baseline Measures
    Drug vs Placebo  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  19.0  ± 14.3  
Gender  
[units: participants]
 
Female     17  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures
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1.  Primary:   Short PTSD Rating Interview (SPRINT)   [ Time Frame: 8 weeks ]

2.  Primary:   Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: 8 weeks ]

3.  Secondary:   Sleep Latency   [ Time Frame: 8 weeks ]

4.  Secondary:   Total Sleep Time   [ Time Frame: 8 weeks ]

5.  Secondary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Week 3 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Mark Pollack
Organization: Massachusetts General Hospital
phone: 312-942-5372
e-mail: mark_pollack@rush.edu


Publications of Results:

Responsible Party: Mark H. Pollack, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00120250     History of Changes
Other Study ID Numbers: 2005-P-000645
Study First Received: July 7, 2005
Results First Received: July 19, 2013
Last Updated: December 26, 2013
Health Authority: United States: Institutional Review Board