InsomniaNCT00645944

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

A study testing Eszopiclone in people with Insomnia and Schizophrenia, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Insomnia, Schizophrenia, Schizoaffective Disorder
What is being tested?: Eszopiclone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Apr 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be between the ages of 18 to 64
Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
Sleep difficulties at least 2x per week in the preceding month
Be on a stable dose of antipsychotic medication
Symptomatically stable in the last 2 months
English speaking.

Who cannot join

Meet criteria for current alcohol or other substance dependence
A history of dementia, mental retardation or other neurological disorder
Not capable of giving informed consent for participation in this study.
Ongoing pregnancy
Known sensitivity to zopiclone.
Insomnia associated with medical disorders likely to impair sleep.

Show all 10Show fewer

Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
Lack of sleep benefit from previous adequate eszopiclone treatment
History of clinically significant hepatic impairment.
Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.

Trial locations and contacts

1 site in 1 country.

United States1 site

Connecticut Mental Health Center
New Haven, Connecticut, 06519

Other trials in United States

About this study

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.

Read the detailed description

The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Conditions: Insomnia, Schizophrenia, Schizoaffective Disorder, Sleep Disorders
Being tested: Eszopiclone, Placebo
Medical subject headings: Sleep Initiation and Maintenance Disorders, Schizophrenia, Psychotic Disorders, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EszopicloneDrug
Also called Lunesta
Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
PlaceboDrug
Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Study groups in NCT00645944
Study group	Role	What they receive
Eszopiclone Group	Experimental	Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Receives: Drug: Eszopiclone
Placebo Group	Placebo comparator	Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Insomnia Severity Index From Baseline.
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 ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.
Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Apr 2011

First posted28 Mar 2008 (estimated)
Study startApr 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00645944
Sponsor's protocol ID: 0702002331
Other IDs: ESRC131
Status last verified: Jun 2015
First submitted: 25 Mar 2008
Last updated: 16 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
ClinicalTrials.gov ID: NCT00645944
Acronym / sponsor ID: 0702002331
Conditions: Insomnia, Schizophrenia, Schizoaffective Disorder, Sleep Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Sumitomo Pharma America, Inc.
Study start: Apr 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 28 Mar 2008 (estimated)
Results: Posted 16 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Eszopiclone Group	Experimental	Drug: EszopicloneParticipants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.
Placebo Group	Placebo comparator	Drug: PlaceboParticipants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Be between the ages of 18 to 64
Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
Sleep difficulties at least 2x per week in the preceding month
Be on a stable dose of antipsychotic medication
Symptomatically stable in the last 2 months

Key exclusion criteria (10 listed)

Meet criteria for current alcohol or other substance dependence
A history of dementia, mental retardation or other neurological disorder
Not capable of giving informed consent for participation in this study.
Ongoing pregnancy
Known sensitivity to zopiclone.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EszopicloneAlso: LunestaEszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Drug	Eszopiclone Group
PlaceboPlacebo or inactive substance ("sugar pill")taken each night for all weeks of the study	Drug	Placebo Group

Primary outcome

Change in Insomnia Severity Index From Baseline.
Time frame: 8 Weeks
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 ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.

Results and safety

Results posted to the registry on 16 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eszopiclone Group	20	19
Placebo Group	19	17

Primary outcome: Change in Insomnia Severity Index From Baseline.

Time frame: 8 Weeks. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Eszopiclone Group n = 19	Placebo Group n = 17
Value	-10.7 (-13.2 to -8.2)	-6.9 (-9.5 to -4.3)

Eszopiclone Group vs Placebo Group: Mean Difference (Final Values): -3.8 (95% CI -7.5 to -0.2), p = 0.039, Mixed Models Analysis

Population analysed: Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis

Adverse events

Time frame: 8 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eszopiclone Group	3 of 19 (15.8%)	16 of 19 (84.2%)	Not reported
Placebo Group	1 of 17 (5.9%)	13 of 17 (76.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Recruiting
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Recruiting
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RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cenk Tek, M.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Eszopiclone in people with Insomnia and Schizophrenia, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insomnia Severity Index From Baseline. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00645944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.