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

NCT00368030 | Completed Phase 3

• 1 other identifier: 190-052
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 65

Brief Summary

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

Conditions

Insomnia; Depressive Disorder, Major

Keywords

Insomnia related to major depressive disorder.

Outcome Measures

Primary Outcomes (1)

• Mean subjective wake time after sleep onset (WASO)

  1 week

Secondary Outcomes (24)

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

• Mean WASO

  Weeks 2, 3, 4, 6 and 8

• Mean subjective total sleep time (TST)

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

• Mean subjective sleep latency (SL)

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

• Mean number of awakenings

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

Study Arms (2)

A

EXPERIMENTAL

Eszopiclone 3 mg QD

Drug: Eszopiclone

B

PLACEBO COMPARATOR

Placebo tablet

Other: Placebo

Interventions

Eszopiclone DRUG

Eszopiclone 3 mg QD

Also known as: Lunesta, (S)-Zopliclone

A

Placebo OTHER

Placebo tablet

B

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (65)

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Birmingham, Alabama, United States

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Peoria, Arizona, United States

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Tucson, Arizona, United States

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Fayetteville, Arkansas, United States

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Garden Grove, California, United States

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Irvine, California, United States

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Northridge, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Wheat Ridge, Colorado, United States

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New Britian, Connecticut, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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North Miami, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Smyrna, Georgia, United States

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Boise, Idaho, United States

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Overland Park, Kansas, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Braintree, Massachusetts, United States

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Brighton, Massachusetts, United States

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Brockton, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Watertown, Massachusetts, United States

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Farmington Hills, Michigan, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Clementon, New Jersey, United States

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Morestown, New Jersey, United States

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Lawerence, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Springfield, Oregon, United States

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Conshohocken, Pennsylvania, United States

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Emmaus, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Anderson, South Carolina, United States

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Madison, Tennessee, United States

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Memphis, Tennessee, United States

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Selmer, Tennessee, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Lakewood, Washington, United States

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Seatle, Washington, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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Related Publications (2)

• 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.

  PMID: 20571180 RESULT

• 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.

  PMID: 21208574 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2006
• First Posted: August 24, 2006
• Study Start: January 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (65)