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

Sponsor

Sunovion (Industry)

Overall Status

Completed

CT.gov ID

NCT00368030

Collaborator

(none)

545

Enrollment

Locations

Arms

Duration (Months)

8.4

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia Depressive Disorder, Major	Drug: Eszopiclone Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

545 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Eszopiclone 3 mg QD	Drug: Eszopiclone Eszopiclone 3 mg QD Other Names: Lunesta, (S)-Zopliclone
Placebo Comparator: B Placebo tablet	Other: Placebo Placebo tablet

Arm

Intervention/Treatment

Experimental: A

Eszopiclone 3 mg QD

Drug: Eszopiclone

Eszopiclone 3 mg QD

Other Names:

Lunesta, (S)-Zopliclone

Placebo Comparator: B

Placebo tablet

Other: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

Mean subjective wake time after sleep onset (WASO) [1 week]

Secondary Outcome Measures

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]
Quality and depth of sleep [Weeks 1, 2, 3, 4, 6 and 8]
Daytime alertness [Weeks 1, 2, 3, 4, 6 and 8]
Ability to concentrate [Weeks 1, 2, 3, 4, 6 and 8]
Physical well-being [Weeks 1, 2, 3, 4, 6 and 8]
Ability to function [Weeks 1, 2, 3, 4, 6, and 8]
average rebound and withdrawal effects will be analyzed for each of the subjective sleep endpoints [Weeks 1, 2, 3, 4, 6, and 8]
Time to onset of 50% antidepressant response using the HAM-D-6 (Bech) [Weeks 1, 2, 3, 4, 6, and 8]
Time to onset of 50% and 30% antidepressant responses using the HAM-D-6 (Maier) [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 [Weeks 1, 2, 3, 4, 6, and 8]
Change in the HAM-D-17 from baseline [Weeks 4 and 8]
Symptom Questionnaire (SQ) Score (Depression Subscale) [Weeks 1, 2, 3, 4, 6, and 8]
Daily Telephone Assessment (DTA) Score [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 [Weeks 8 and 10]
SF-36 Score [Weeks 4, 8, and 10]
Work Limitations Questionnaire (WLQ) Score [Weeks 2, 4, 8, and 10]
Epworth Sleepiness Scale (ESS) [Weeks 1, 2, 3, 4, 6, 8, and 10]
Insomnia Severity Index (ISI) score [Weeks 2, 4, 8, and 10]
Clinical Global Impression [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 [Weeks 1 through 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Peoria	Arizona	United States
3	Tucson	Arizona	United States
4	Fayetteville	Arkansas	United States
5	Garden Grove	California	United States
6	Irvine	California	United States
7	Northridge	California	United States
8	Riverside	California	United States
9	San Diego	California	United States
10	Wheat Ridge	Colorado	United States
11	New Britian	Connecticut	United States
12	Jacksonville	Florida	United States
13	Miami Beach	Florida	United States
14	Miami	Florida	United States
15	North Miami	Florida	United States
16	St. Petersburg	Florida	United States
17	Atlanta	Georgia	United States
18	Augusta	Georgia	United States
19	Decatur	Georgia	United States
20	Smyrna	Georgia	United States
21	Boise	Idaho	United States
22	Overland Park	Kansas	United States
23	Rockville	Maryland	United States
24	Boston	Massachusetts	United States
25	Braintree	Massachusetts	United States
26	Brighton	Massachusetts	United States
27	Brockton	Massachusetts	United States
28	Cambridge	Massachusetts	United States
29	Watertown	Massachusetts	United States
30	Farmington Hills	Michigan	United States
31	St Louis	Missouri	United States
32	Omaha	Nebraska	United States
33	Clementon	New Jersey	United States
34	Morestown	New Jersey	United States
35	Bronx	New York	United States
36	Lawerence	New York	United States
37	New York	New York	United States
38	Durham	North Carolina	United States
39	Winston-Salem	North Carolina	United States
40	Bismarck	North Dakota	United States
41	Beachwood	Ohio	United States
42	Cincinatti	Ohio	United States
43	Dayton	Ohio	United States
44	Oklahoma City	Oklahoma	United States
45	Eugene	Oregon	United States
46	Portland	Oregon	United States
47	Salem	Oregon	United States
48	Springfield	Oregon	United States
49	Conshohocken	Pennsylvania	United States
50	Emmaus	Pennsylvania	United States
51	Philadelphia	Pennsylvania	United States
52	Scotland	Pennsylvania	United States
53	Anderson	South Carolina	United States
54	Madison	Tennessee	United States
55	Memphis	Tennessee	United States
56	Selmer	Tennessee	United States
57	Austin	Texas	United States
58	San Antonio	Texas	United States
59	Wichita Falls	Texas	United States
60	Salt Lake City	Utah	United States
61	Richmond	Virginia	United States
62	Lakewood	Washington	United States
63	Seatle	Washington	United States
64	Spokane	Washington	United States
65	Madison	Wisconsin	United States