Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

August 26, 2014 updated by: Dara S. Manoach, PhD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eszopiclone
3mg of eszopiclone on two consecutive nights
Drug: eszopiclone
3 mg of eszopiclone at bedtime on two consecutive nights
Other Names:
  • Lunesta
Placebo Comparator: placebo
placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
Drug: placebo
Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Train on Day 3 and Test on Day 4 of study (experimental nights)
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)
during two nights in an inpatient Clinical Research Center

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Beth Israel Deaconess Medical Center
Sunovion

Investigators

  • Principal Investigator: Dara S. Manoach, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sepracor051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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