Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

NCT ID: NCT00833547

Last Updated: 2014-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-09-30

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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eszopiclone

3mg of eszopiclone on two consecutive nights

Group Type EXPERIMENTAL

eszopiclone

Intervention Type DRUG

3 mg of eszopiclone at bedtime on two consecutive nights

placebo

placebo capsule that looks identical to eszopiclone capsule on two consecutive nights

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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eszopiclone

3 mg of eszopiclone at bedtime on two consecutive nights

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Lunesta

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dara S. Manoach, PhD

Associate Professor of Psychology, Dept. of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dara S. Manoach, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Mass General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Sepracor051

Identifier Type: -

Identifier Source: org_study_id

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