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Completed

NCT Number: NCT00833547

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eszopiclone

Drug

3 mg of eszopiclone at bedtime on two consecutive nights

Other names: Lunesta

Placebo

Drug

Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights

Primary outcomes

  1. Overnight Change on Finger Tapping Task

    Time frame: Train on Day 3 and Test on Day 4 of study (experimental nights)

    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.

  2. Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography

    Time frame: during two nights in an inpatient Clinical Research Center

    2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Sumitomo Pharma America, Inc.

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2009
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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