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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

January 29, 2009
August 26, 2014
September 2006
September 2012   (final data collection date for primary outcome measure)
  • Overnight Change on Finger Tapping Task [ Time Frame: Train on Day 3 and Test on Day 4 of study (experimental nights) ] [ Designated as safety issue: No ]
    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 During Stage 2 Sleep as Measured by Polysomnography [ Time Frame: during two nights in an inpatient Clinical Research Center ] [ Designated as safety issue: No ]
    2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)
Sleep-dependent motor skill learning [ Time Frame: Day 4 of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00833547 on ClinicalTrials.gov Archive Site
Not Provided
Sleep architecture and sleep latency as measured by polysomnography [ Time Frame: during four nights in GCRC ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Schizophrenia
  • Drug: eszopiclone
    3 mg of eszopiclone at bedtime on two consecutive nights
    Other Name: Lunesta
  • Drug: placebo
    Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights
  • Experimental: Eszopiclone
    3mg of eszopiclone on two consecutive nights
    Intervention: Drug: eszopiclone
  • Placebo Comparator: placebo
    placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia

Exclusion Criteria:

  • History of neurologic or psychiatric disease other than schizophrenia
  • Substance abuse or dependence within the past six months
  • Other chronic medical conditions that affect sleep
  • Pregnancy/breast feeding
  • Hepatic impairment
  • Treatment with metabolic inhibitors or inducers
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833547
Sepracor051
No
Dara S. Manoach, PhD, Massachusetts General Hospital
Massachusetts General Hospital
  • Sunovion
  • Beth Israel Deaconess Medical Center
Principal Investigator: Dara S. Manoach, PhD Massachusetts General Hospital
Massachusetts General Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP