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NCT00645944 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Yale University.

Completed
Registry status
NA
Development phase
39
Enrollment target

NCT00645944: Completed NA study, sponsored by Yale University.

NCT00645944 is a NA study that has completed, run by Yale University. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00645944, a NA study, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
39 participants
Enrollment target

Study 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.

Primary Outcome

The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach's alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The I

Interventions

  • DRUG Placebo
  • DRUG Eszopiclone

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2008-04
Est. Completion 2011-04
Phase NA
Yale University

1,492 total trials

What the finished NCT00645944 record still lists

NCT00645944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00645944 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00645944 about?

NCT00645944 is a clinical study titled "Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia". 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 associ...

What is the current status of trial NCT00645944?

This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2008-04. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00645944?

The interventions under investigation include: Placebo (DRUG), Eszopiclone (DRUG).

Who is sponsoring clinical trial NCT00645944?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00645944's enrollment target sits among peer trials

39 1536th of 2000 higher than 463 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00645944, the US trial registry maintained by the National Library of Medicine. NCT00645944 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.