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Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Sunovion
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Dara S. Manoach, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833547
First received: January 29, 2009
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition: Schizophrenia
Interventions: Drug: eszopiclone
Drug: placebo

  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
Placebo placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
Eszopiclone 3mg of eszopiclone at bedtime for two consecutive nights

Participant Flow:   Overall Study
    Placebo     Eszopiclone  
STARTED     13     12  
COMPLETED     11     10  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 2  



  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.
No text entered.

Reporting Groups
  Description
Eszopiclone 3mg of eszopiclone at bedtime on 2 consecutive nights
Placebo placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
Total Total of all reporting groups

Baseline Measures
    Eszopiclone     Placebo     Total  
Number of Participants  
[units: participants]
  10     11     21  
Age  
[units: years]
Mean ± Standard Deviation
  35  ± 10     34  ± 9     34  ± 9  
Gender  
[units: participants]
     
Female     3     1     4  
Male     7     10     17  
Overnight change on finger tapping task [1]
[units: percent change]
Mean ± Standard Deviation
  8  ± 19     -5  ± 25     2  ± 23  
sleep spindle density [2]
[units: spindles per minute]
Mean ± Standard Deviation
  1.57  ± .56     1.08  ± .43     1.3  ± .5  
[1] The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) "as quickly and accurately as possible" for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning.
[2] spindles per minute during Stage 2 sleep



  Outcome Measures
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1.  Primary:   Overnight Change on Finger Tapping Task   [ Time Frame: Train on Day 3 and Test on Day 4 of study (experimental nights) ]

2.  Primary:   Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography   [ Time Frame: during two nights in an inpatient Clinical Research Center ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Dr. Dara Manoach
Organization: Massachusetts General Hospital
phone: 617-726-6148
e-mail: dara@nmr.mgh.harvard.edu


No publications provided


Responsible Party: Dara S. Manoach, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833547     History of Changes
Other Study ID Numbers: Sepracor051
Study First Received: January 29, 2009
Results First Received: July 17, 2014
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board