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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00368030
First received: August 23, 2006
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Insomnia
Depressive Disorder, Major
Drug: Eszopiclone
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Mean subjective wake time after sleep onset (WASO) [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of 30% antidepressant response using the HAM-D-6 (Bech) [ Designated as safety issue: No ]
  • Mean WASO [ Time Frame: Weeks 2, 3, 4, 6 and 8 ] [ Designated as safety issue: No ]
  • Mean subjective total sleep time (TST) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Mean subjective sleep latency (SL) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Mean number of awakenings [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Quality and depth of sleep [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ] [ Designated as safety issue: No ]
  • Daytime alertness [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ] [ Designated as safety issue: No ]
  • Ability to concentrate [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ] [ Designated as safety issue: No ]
  • Physical well-being [ Time Frame: Weeks 1, 2, 3, 4, 6 and 8 ] [ Designated as safety issue: No ]
  • Ability to function [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to onset of 50% antidepressant response using the HAM-D-6 (Bech) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in the HAM-D-17 from baseline [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Symptom Questionnaire (SQ) Score (Depression Subscale) [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Daily Telephone Assessment (DTA) Score [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • SF-36 Score [ Time Frame: Weeks 4, 8, and 10 ] [ Designated as safety issue: No ]
  • Work Limitations Questionnaire (WLQ) Score [ Time Frame: Weeks 2, 4, 8, and 10 ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]
  • Insomnia Severity Index (ISI) score [ Time Frame: Weeks 2, 4, 8, and 10 ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, and 10 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 545
Study Start Date: January 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Eszopiclone 3 mg QD
Drug: Eszopiclone
Eszopiclone 3 mg QD
Other Name: Lunesta, (S)-Zopliclone
Placebo Comparator: B
Placebo tablet
Other: Placebo
Placebo tablet

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.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368030

  Show 65 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

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. The Journal of Mental Health Policy and Economics 2010;13:27-35.
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. Journal of Clinical Psychiatry 2010; doi::10.4088/JCP.09m05131gry

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00368030     History of Changes
Other Study ID Numbers: 190-052
Study First Received: August 23, 2006
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Insomnia related to major depressive disorder.

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014