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

Primary Purpose

Insomnia, Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia related to major depressive disorder.

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Eszopiclone 3 mg QD

Placebo tablet

Outcomes

Primary Outcome Measures

Mean subjective wake time after sleep onset (WASO)

Secondary Outcome Measures

Time to onset of 30% antidepressant response using the HAM-D-6 (Bech)
Mean WASO
Mean subjective total sleep time (TST)
Mean subjective sleep latency (SL)
Mean number of awakenings
Quality and depth of sleep
Daytime alertness
Ability to concentrate
Physical well-being
Ability to function
average rebound and withdrawal effects will be analyzed for each of the subjective sleep endpoints
Time to onset of 50% antidepressant response using the HAM-D-6 (Bech)
Time to onset of 50% and 30% antidepressant responses using the HAM-D-6 (Maier)
Change in the HAM-D-6 (Bech) and HAM-D-6 (Maier) from baseline to each visit
Change in the HAM-D-17 from baseline
Symptom Questionnaire (SQ) Score (Depression Subscale)
Daily Telephone Assessment (DTA) Score
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
SF-36 Score
Work Limitations Questionnaire (WLQ) Score
Epworth Sleepiness Scale (ESS)
Insomnia Severity Index (ISI) score
Clinical Global Impression
Safety will be assessed by physical examinations, a standard 12-lead ECG, vital signs, clinical laboratory assessments and AE reporting

Full Information

First Posted
August 23, 2006
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00368030
Brief Title
A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depressive Disorder, Major
Keywords
Insomnia related to major depressive disorder.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Eszopiclone 3 mg QD
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta, (S)-Zopliclone
Intervention Description
Eszopiclone 3 mg QD
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Mean subjective wake time after sleep onset (WASO)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Time to onset of 30% antidepressant response using the HAM-D-6 (Bech)
Title
Mean WASO
Time Frame
Weeks 2, 3, 4, 6 and 8
Title
Mean subjective total sleep time (TST)
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Mean subjective sleep latency (SL)
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Mean number of awakenings
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Quality and depth of sleep
Time Frame
Weeks 1, 2, 3, 4, 6 and 8
Title
Daytime alertness
Time Frame
Weeks 1, 2, 3, 4, 6 and 8
Title
Ability to concentrate
Time Frame
Weeks 1, 2, 3, 4, 6 and 8
Title
Physical well-being
Time Frame
Weeks 1, 2, 3, 4, 6 and 8
Title
Ability to function
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
average rebound and withdrawal effects will be analyzed for each of the subjective sleep endpoints
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Time to onset of 50% antidepressant response using the HAM-D-6 (Bech)
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Time to onset of 50% and 30% antidepressant responses using the HAM-D-6 (Maier)
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Change in the HAM-D-6 (Bech) and HAM-D-6 (Maier) from baseline to each visit
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Change in the HAM-D-17 from baseline
Time Frame
Weeks 4 and 8
Title
Symptom Questionnaire (SQ) Score (Depression Subscale)
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
Daily Telephone Assessment (DTA) Score
Time Frame
Weeks 1, 2, 3, 4, 6, and 8
Title
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
Time Frame
Weeks 8 and 10
Title
SF-36 Score
Time Frame
Weeks 4, 8, and 10
Title
Work Limitations Questionnaire (WLQ) Score
Time Frame
Weeks 2, 4, 8, and 10
Title
Epworth Sleepiness Scale (ESS)
Time Frame
Weeks 1, 2, 3, 4, 6, 8, and 10
Title
Insomnia Severity Index (ISI) score
Time Frame
Weeks 2, 4, 8, and 10
Title
Clinical Global Impression
Time Frame
Weeks 1, 2, 3, 4, 6, 8, and 10
Title
Safety will be assessed by physical examinations, a standard 12-lead ECG, vital signs, clinical laboratory assessments and AE reporting
Time Frame
Weeks 1 through 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
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Peoria
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Arizona
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United States
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Tucson
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Arizona
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Fayetteville
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Arkansas
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United States
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Garden Grove
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California
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United States
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Irvine
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California
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United States
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Northridge
State/Province
California
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United States
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Riverside
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California
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United States
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San Diego
State/Province
California
Country
United States
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Wheat Ridge
State/Province
Colorado
Country
United States
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New Britian
State/Province
Connecticut
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United States
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Jacksonville
State/Province
Florida
Country
United States
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Miami Beach
State/Province
Florida
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United States
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Miami
State/Province
Florida
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United States
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North Miami
State/Province
Florida
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United States
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St. Petersburg
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Florida
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United States
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Atlanta
State/Province
Georgia
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United States
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Augusta
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Georgia
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United States
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Decatur
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Georgia
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Smyrna
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Georgia
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Boise
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Idaho
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United States
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Overland Park
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Kansas
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United States
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Rockville
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Maryland
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United States
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Boston
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Massachusetts
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United States
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Braintree
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Massachusetts
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United States
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Brighton
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Massachusetts
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Brockton
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Massachusetts
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Cambridge
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Massachusetts
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United States
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Watertown
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Massachusetts
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Farmington Hills
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Michigan
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United States
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St Louis
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Missouri
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United States
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Omaha
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Nebraska
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United States
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Clementon
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New Jersey
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Morestown
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New Jersey
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United States
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Bronx
State/Province
New York
Country
United States
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Lawerence
State/Province
New York
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United States
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New York
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New York
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United States
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Durham
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North Carolina
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United States
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Winston-Salem
State/Province
North Carolina
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United States
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Bismarck
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North Dakota
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United States
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Beachwood
State/Province
Ohio
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United States
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Cincinatti
State/Province
Ohio
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United States
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Dayton
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Ohio
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United States
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Oklahoma City
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Oklahoma
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United States
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Eugene
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Oregon
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United States
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Portland
State/Province
Oregon
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United States
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Salem
State/Province
Oregon
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United States
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Springfield
State/Province
Oregon
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United States
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Conshohocken
State/Province
Pennsylvania
Country
United States
City
Emmaus
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Scotland
State/Province
Pennsylvania
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Madison
State/Province
Tennessee
Country
United States
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Memphis
State/Province
Tennessee
Country
United States
City
Selmer
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Wichita Falls
State/Province
Texas
Country
United States
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Salt Lake City
State/Province
Utah
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Lakewood
State/Province
Washington
Country
United States
City
Seatle
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20571180
Citation
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.
Results Reference
result
PubMed Identifier
21208574
Citation
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.
Results Reference
result

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

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