Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: placebo; Drug: eszopiclone

• Registration Number: NCT00833547
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2014-07-17
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-26
• Last Update Submitted: 2014-08-26
• Results First Posted: 2014-09-09
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
Eszopiclone	eszopiclone	3mg of eszopiclone on two consecutive nights

Primary Outcome Measures

Name	Time	Method
Overnight Change on Finger Tapping Task	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.
Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography	during two nights in an inpatient Clinical Research Center	2 baseline nights (Days 1 \&2); 2 experimental nights (Days 3 \&4)

Trial Locations

Locations (1)

Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States