Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

This study is ongoing, but not recruiting participants.

First Received on January 29, 2009. Last Updated on July 19, 2011 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborators:	Sunovion Beth Israel Deaconess Medical Center
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00833547

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:

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 February 09, 2012