Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00368030
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Sunovion

Tracking Information
First Submitted Date  ICMJE August 23, 2006
First Posted Date  ICMJE August 24, 2006
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE January 2004
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Mean subjective wake time after sleep onset (WASO) [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00368030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Time to onset of 30% antidepressant response using the HAM-D-6 (Bech)
  • Mean WASO [ Time Frame: Weeks 2, 3, 4, 6 and 8 ]
  • Mean subjective total sleep time (TST) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • Mean subjective sleep latency (SL) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • Mean number of awakenings [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • Quality and depth of sleep [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ]
  • Daytime alertness [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ]
  • Ability to concentrate [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ]
  • Physical well-being [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ]
  • Ability to function [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • 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 ]
  • Time to onset of 50% antidepressant response using the HAM-D-6 (Bech) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • 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 ]
  • 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 ]
  • Change in the HAM-D-17 from baseline [ Time Frame: Weeks 4 and 8 ]
  • Symptom Questionnaire (SQ) Score (Depression Subscale) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • Daily Telephone Assessment (DTA) Score [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
  • 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 ]
  • SF-36 Score [ Time Frame: Weeks 4, 8, and 10 ]
  • Work Limitations Questionnaire (WLQ) Score [ Time Frame: Weeks 2, 4, 8, and 10 ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, and 10 ]
  • Insomnia Severity Index (ISI) score [ Time Frame: Weeks 2, 4, 8, and 10 ]
  • Clinical Global Impression [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, and 10 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Eszopiclone
    Eszopiclone 3 mg QD
    Other Name: Lunesta, (S)-Zopliclone
  • Other: Placebo
    Placebo tablet
Study Arms  ICMJE
  • Experimental: A
    Eszopiclone 3 mg QD
    Intervention: Drug: Eszopiclone
  • Placebo Comparator: B
    Placebo tablet
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2008)
545
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2004
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00368030
Other Study ID Numbers  ICMJE 190-052
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sunovion
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP