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: October 25, 2013
Last verified: October 2013

January 29, 2009
October 25, 2013
September 2006
September 2012   (final data collection date for primary outcome measure)
Sleep-dependent motor skill learning [ Time Frame: Day 4 of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833547 on ClinicalTrials.gov Archive Site
Sleep architecture and sleep latency as measured by polysomnography [ Time Frame: during four nights in GCRC ] [ Designated as safety issue: No ]
Same as current
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
Experimental: Eszopiclone
3mg of eszopiclone on two consecutive nights
Intervention: Drug: eszopiclone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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
October 2013

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