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InsomniaPhase 3NCT00368030

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

A Phase 3 study testing Eszopiclone in people with Insomnia and Depressive Disorder, Major, run by Sumitomo Pharma America, Inc. at 65 sites 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

The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia related to major depressive disorder. Read more about this study

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Insomnia, Depressive Disorder, Major
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
545 participants
Where
65 sitesUnited States
Study dates
Jan 2004to Oct 2004
Phase
Phase 3
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 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
  • Subject must be 21 to 64 years of age (inclusive) on the day of signing consent.
  • Subject must meet criteria for a primary and principal diagnosis of Major Depressive Disorder.
  • Subject's current depressive episode is at least 2 weeks but not longer than 6 months in duration.
  • Subject must meet criteria for insomnia related to MDD and the symptoms of insomnia must not pre-date the symptoms of MDD by more than 10 weeks.
  • Subject must report a sleep onset time of > 30 minutes, and wake time after sleep onset of > 45 minutes, and < 6.5 hours of total sleep time at least three times a week over the previous month.
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  • Subject must take the Hamilton-D-17 scale and have a protocol pre-specified minimum score.
  • Subject must have no known clinically significant abnormal laboratory, ECG, or physical examination findings at screening.
  • Subject must meet one of the following conditions:
  • Subject is not taking antidepressant medications at the time of study start.
  • Subject is taking a sub-therapeutic dose of antidepressant or other disallowed psychotropic medication and with the approval of the investigator agrees to taper off of this medication, prior to completion of screening assessments at study start.

Who cannot join

  • Female subject is pregnant, lactating or within 6 months post partum.
  • Subject has known sensitivity to any selective SSRI, zopiclone, or eszopiclone.
  • Subject has history of major depressive disorder that was refractory to treatment with SSRIs.
  • Subject has a current primary psychiatric diagnosis of any of the following disorders: dementia, delirium, schizophrenia, psychosis, other psychotic disorders, dysthymic disorder; bipolar disorders; cyclothymic disorder, other mood disorders, nocturnal panic disorder, primary anxiety disorders, primary panic disorders or any other psychiatric disorder that would compromise the investigator's ability to evaluate the safety and efficacy of the study medication.
  • Note: Subjects with Sexual and Gender Identity Disorders or other non-psychotic disorders will be considered on a case-by-case basis. Subjects with MDD and a secondary diagnosis of generalized anxiety disorder, panic disorders other than nocturnal panic disorder or seasonal affective disorder will be allowed.
  • Subject has any of the following Personality Disorders diagnoses: schizotypal, schizoid, borderline personality disorder; mental retardation or any other personality disorder that would compromise the investigator's ability to evaluate the safety and efficacy of the study medication.
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  • Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis [e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS)], or has any condition that has or may affect sleep [(e.g., chronic pain, benign prostatic hypertrophy (BPH)].
  • Subject has any clinically significant unstable medical or neurologic abnormality, unstable chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
  • Subject has a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
  • Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
  • Subject has a history of drug or alcohol abuse or dependence in the past 6 months or positive urine drug and alcohol test at screening.
  • Subject is participating in, has participated in, or plans to participate in any investigational drug study within 30 days prior to screening until the end of this study.
  • Subject has history of circadian rhythm disorder, or travels across >3 time zones on a regular basis.
  • Subject is known to be seropositive for Human Immunodeficiency Virus (HIV).
  • Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
  • Subject is unwilling to refrain from drinking alcoholic beverages during study participation.
  • Subject is a rotating or third/night shift worker.
  • Subject is a staff member or relative of a staff member.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Beachwood, Ohio

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Braintree, Massachusetts

  • Study site

    Brighton, Massachusetts

  • Study site

    Brockton, Massachusetts

  • Study site

    Cambridge, Massachusetts

  • Study site

    Cincinnati, Ohio

  • Study site

    Clementon, New Jersey

  • Study site

    Conshohocken, Pennsylvania

  • Study site

    Dayton, Ohio

  • Study site

    Decatur, Georgia

  • Study site

    Durham, North Carolina

  • Study site

    Emmaus, Pennsylvania

  • Study site

    Eugene, Oregon

  • Study site

    Farmington Hills, Michigan

  • Study site

    Fayetteville, Arkansas

  • Study site

    Garden Grove, California

  • Study site

    Irvine, California

  • Study site

    Jacksonville, Florida

  • Study site

    Lakewood, Washington

  • Study site

    Lawerence, New York

  • Study site

    Madison, Tennessee

  • Study site

    Madison, Wisconsin

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Miami Beach, Florida

  • Study site

    Morestown, New Jersey

  • Study site

    New Britian, Connecticut

  • Study site

    New York, New York

  • Study site

    North Miami, Florida

  • Study site

    Northridge, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Overland Park, Kansas

  • Study site

    Peoria, Arizona

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    Rockville, Maryland

  • Study site

    Salem, Oregon

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Scotland, Pennsylvania

  • Study site

    Seatle, Washington

  • Study site

    Selmer, Tennessee

  • Study site

    Smyrna, Georgia

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Oregon

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    The Bronx, New York

  • Study site

    Tucson, Arizona

  • Study site

    Watertown, Massachusetts

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wichita Falls, Texas

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Depression Response to Eszopiclone in Adults With Major Depressive Disorder (DREAMDD): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 8-Week, Safety & Efficacy Study of Eszopiclone 3 mg Compared to Placebo in Subjects With Insomnia Related to MDD Acronym: DREAMDD

The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia related to major depressive disorder.

Read the detailed description

This study is a double-blind, randomized, placebo-controlled, parallel group study. The study consists of two groups of subjects with major depression treated for ten weeks with a common antidepressant regimen, 20-40 mg of fluoxetine hydrochloride per day; and randomized to receive (in addition) either eszopiclone 3 mg or placebo for eight 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.

Being tested
Eszopiclone, Placebo
Keywords
Insomnia related to major depressive disorder.
Medical subject headings
Sleep Initiation and Maintenance Disorders, Depressive Disorder, Major

What participants receive

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

  • EszopicloneDrug

    Also called Lunesta, (S)-Zopliclone

    Eszopiclone 3 mg QD

  • PlaceboOther

    Placebo tablet

Study groups in NCT00368030
Study groupRoleWhat they receive
AExperimentalEszopiclone 3 mg QD
Receives: Drug: Eszopiclone
BPlacebo comparatorPlacebo tablet
Receives: Other: Placebo

What is being measured

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

  1. Mean subjective wake time after sleep onset (WASO)

    Measured: 1 week

Secondary outcomes (24)

  1. Time to onset of 30% antidepressant response using the HAM-D-6 (Bech)

  2. Mean WASO

    Measured: Weeks 2, 3, 4, 6 and 8

  3. Mean subjective total sleep time (TST)

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  4. Mean subjective sleep latency (SL)

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  5. Mean number of awakenings

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  6. Quality and depth of sleep

    Measured: Weeks 1, 2, 3, 4, 6 and 8

  7. Daytime alertness

    Measured: Weeks 1, 2, 3, 4, 6 and 8

  8. Ability to concentrate

    Measured: Weeks 1, 2, 3, 4, 6 and 8

  9. Physical well-being

    Measured: Weeks 1, 2, 3, 4, 6 and 8

  10. Ability to function

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  11. average rebound and withdrawal effects will be analyzed for each of the subjective sleep endpoints

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  12. Time to onset of 50% antidepressant response using the HAM-D-6 (Bech)

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  13. Time to onset of 50% and 30% antidepressant responses using the HAM-D-6 (Maier)

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  14. Change in the HAM-D-6 (Bech) and HAM-D-6 (Maier) from baseline to each visit

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  15. Change in the HAM-D-17 from baseline

    Measured: Weeks 4 and 8

  16. Symptom Questionnaire (SQ) Score (Depression Subscale)

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  17. Daily Telephone Assessment (DTA) Score

    Measured: Weeks 1, 2, 3, 4, 6, and 8

  18. Change in HAM-D-6 (Bech), HAM-D-6 (Maier), HAM-D-17, SQ, and DTA during the wash-out phase until end of study

    Measured: Weeks 8 and 10

  19. SF-36 Score

    Measured: Weeks 4, 8, and 10

  20. Work Limitations Questionnaire (WLQ) Score

    Measured: Weeks 2, 4, 8, and 10

  21. Epworth Sleepiness Scale (ESS)

    Measured: Weeks 1, 2, 3, 4, 6, 8, and 10

  22. Insomnia Severity Index (ISI) score

    Measured: Weeks 2, 4, 8, and 10

  23. Clinical Global Impression

    Measured: Weeks 1, 2, 3, 4, 6, 8, and 10

  24. Safety will be assessed by physical examinations, a standard 12-lead ECG, vital signs, clinical laboratory assessments and AE reporting

    Measured: Weeks 1 through 10

Timeline

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

  1. First posted24 Aug 2006 (estimated)
  2. Study startJan 2004
  3. Primary completionOct 2004
  4. Study completionOct 2004

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368030
Sponsor's protocol ID
190-052
Status last verified
Feb 2012
First submitted
23 Aug 2006
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Snedecor SJ, Botteman MF, Schaefer K, Sarocco P, Barry N, Pickard AS. Economic outcomes of eszopiclone treatment in insomnia and comorbid major depressive disorder. J Ment Health Policy Econ. 2010 Mar;13(1):27-35.

    PubMed 20571180

  • 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 21208574

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eszopiclone in people with Insomnia and Depressive Disorder, Major, run by Sumitomo Pharma America, Inc. at 65 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?

The sponsor lists 11 inclusion and 18 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 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 65 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. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Mean subjective wake time after sleep onset (WASO) (time frame: 1 week). 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 NCT00368030, 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.

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