InsomniaPhase 4NCT00235508
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
A Phase 4 study testing Eszopiclone (Lunesta) in people with Insomnia and Generalized Anxiety Disorder, run by Sumitomo Pharma America, Inc. at 64 sites in United States.
Trial summary
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia, Generalized Anxiety Disorder
- What is being tested?
- Eszopiclone (Lunesta)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 64 sitesUnited States
- Study dates
- Jun 2005to Apr 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Subjects, between the ages of 18 and 64 years inclusive
- Subjects with Generalized Anxiety Disorder (GAD)
- Subjects with insomnia related to GAD.
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
United States64 sites
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Beachwood, Ohio
Study site
Birmingham, Alabama
Study site
Bismarck, North Dakota
Study site
Braintree, Massachusetts
Study site
Brighton, Massachusetts
Study site
Brockton, Massachusetts
Study site
Brooklyn, New York
Study site
Cambridge, Massachusetts
Study site
Cincinnati, Ohio
Study site
Columbia, South Carolina
Study site
Coral Springs, Florida
Study site
Dayton, Ohio
Study site
Durham, North Carolina
Study site
Eugene, Oregon
Study site
Falls Church, Virginia
Study site
Farmington, Connecticut
Study site
Fort Lauderdale, Florida
Study site
Gainesville, Florida
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Irvine, California
Study site
Jacksonville, Florida
Study site
Kenilworth, New Jersey
Study site
La Mesa, California
Study site
Lawrence, New York
Study site
Memphis, Tennessee
Study site
Mesa, Arizona
Study site
Middleburg Heights, Ohio
Study site
Middleton, Wisconsin
Study site
Moon Township, Pennsylvania
Study site
National City, California
Study site
New York, New York
Study site
Northfield, Illinois
Study site
Oceanside, California
Study site
Orange, California
Study site
Orlando, Florida
Study site
Owensboro, Kentucky
Study site
Pasadena, California
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Piscataway, New Jersey
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Redlands, California
Study site
Richardson, Texas
Study site
Richmond, Virginia
Study site
Riverside, California
Study site
Rockville, Maryland
Study site
Salem, Oregon
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Scotland, Pennsylvania
Study site
Scottsdale, Arizona
Study site
Smyrna, Georgia
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Washington D.C., District of Columbia
Study site
Watertown, Massachusetts
Study site
Wichita Falls, Texas
Study site
Winston-Salem, North Carolina
About this study
Official title: The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.
Read the detailed description
An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Insomnia, Generalized Anxiety Disorder
- Being tested
- Eszopiclone (Lunesta)
- Keywords
- Insomnia, Anxiety, Generalized Anxiety Disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eszopiclone (Lunesta)Drug
Also called Lunesta
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Escitalopram oxalate 10 mg at bedtime Receives: Drug: Eszopiclone (Lunesta) |
| 2 | Active comparator | Eszopiclone 3 mg at bedtime Receives: Drug: Eszopiclone (Lunesta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
Measured: 8 weeks
Secondary outcomes (1)
Change from baseline in subjective total sleep time averaged over the double blind treatment period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startJun 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235508
- Sponsor's protocol ID
- 190-902
- Status last verified
- Feb 2012
- First submitted
- 6 Oct 2005
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, Wessel TC. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. J Clin Psychiatry. 2011 Apr;72(4):473-9. doi: 10.4088/JCP.09m05131gry. Epub 2010 Nov 2.
PubMed 21208574Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, Rubens R, Roach J, Huang H, Krishnan R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008 May;65(5):551-62. doi: 10.1001/archpsyc.65.5.551.
PubMed 18458207
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
- ClinicalTrials.gov ID
- NCT00235508
- Acronym / sponsor ID
- 190-902
- Conditions
- Insomnia, Generalized Anxiety Disorder
- Keywords
- Insomnia, Anxiety, Generalized Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.
Detailed description
An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Eszopiclone (Lunesta)Escitalopram oxalate 10 mg at bedtime |
| 2 | Active comparator | Drug: Eszopiclone (Lunesta)Eszopiclone 3 mg at bedtime |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Eszopiclone (Lunesta)Also: LunestaEscitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime | Drug | 1, 2 |
Primary outcome
The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
Time frame: 8 weeks
1 secondary outcome
Change from baseline in subjective total sleep time averaged over the double blind treatment period.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Results publication: PubMed 21208574Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, Wessel TC. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. J Clin Psychiatry. 2011 Apr;72(4):473-9. doi: 10.4088/JCP.09m05131gry. Epub 2010 Nov 2.
- Derived from this study: PubMed 18458207Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, Rubens R, Roach J, Huang H, Krishnan R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008 May;65(5):551-62. doi: 10.1001/archpsyc.65.5.551.
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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.
The record lists no contact. Use the official record to reach the sponsor.
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eszopiclone (Lunesta) in people with Insomnia and Generalized Anxiety Disorder, run by Sumitomo Pharma America, Inc. at 64 sites 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?
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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change from baseline in subjective sleep latency averaged over the double-blind treatment period. (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 NCT00235508, which also lists 2 linked publications.
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 22 Feb 2012.