Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: eszopiclone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eszopiclone<br>3mg of eszopiclone on two consecutive nights | Drug: eszopiclone<br>* 3 mg of eszopiclone at bedtime on two consecutive nights<br>* Other names: Lunesta;|
| Placebo Comparator: placebo<br>placebo capsule that looks identical to eszopiclone capsule on two consecutive nights | Drug: placebo<br>* Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overnight Change on Finger Tapping Task | 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. | Train on Day 3 and Test on Day 4 of study (experimental nights) | 
| Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography | 2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4) | during two nights in an inpatient Clinical Research Center | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, schizophrenia, procedural learning, motor skill