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Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

NCT00645944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-07-16

Study results available
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Summary

The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

Conditions

Interventions

DRUG

Eszopiclone

Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

DRUG

Placebo

Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Cenk Tek, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00645944 on ClinicalTrials.gov