Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833547
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Dara S. Manoach, PhD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition: Schizophrenia
Interventions: Drug: eszopiclone
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
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 
Withdrawal by Subject                2                2 

  Baseline Characteristics

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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
[Units: Years]
Mean (Standard Deviation)
 35  (10)   34  (9)   34  (9) 
[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) 
[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.
sleep spindle density [1] 
[Units: Spindles per minute]
Mean (Standard Deviation)
 1.57  (.56)   1.08  (.43)   1.3  (.5) 
[1] spindles per minute during Stage 2 sleep

  Outcome Measures

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

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

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

Responsible Party: Dara S. Manoach, PhD, Massachusetts General Hospital Identifier: NCT00833547     History of Changes
Other Study ID Numbers: Sepracor051
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: July 17, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014