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Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sunovion
Beth Israel Deaconess Medical Center
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833547
First received: January 29, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Schizophrenia
 Drug: eszopiclone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Eszopiclone
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Sleep-dependent motor skill learning [ Time Frame: Day 4 of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep architecture and sleep latency as measured by polysomnography [ Time Frame: during four nights in GCRC ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: September 2006
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: eszopiclone
    3 mg of eszopiclone at bedtime on two consecutive nights
    Other Name: Lunesta
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833547

Locations
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Sunovion
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Dara S. Manoach, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Dara S. Manoach, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833547     History of Changes
Other Study ID Numbers: Sepracor051
Study First Received: January 29, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
sleep
schizophrenia
procedural learning
motor skill

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013