Back to resultsA Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
Primary Purpose
Major Depressive Disorder, Insomnia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Venlafaxine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Insomnia, Depression, Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
- Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
- MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
- Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of > 22 at the screening visit.
Exclusion Criteria:
- Subjects who have a HAM-D-17 total score < 18 at Visit 2 will be discontinued from the study.
- All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major Depressive Disorder.
- Subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Eszopiclone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
Secondary Outcome Measures
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
Full Information
NCT ID
NCT00435279
First Posted
February 12, 2007
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00435279
Brief Title
A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
Official Title
A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (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
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).
Detailed Description
This is a double-blind, randomized, placebo-controlled, parallel-group study. The study consists of two groups of subjects with Major Depressive Disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine. Safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. 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
Major Depressive Disorder, Insomnia
Keywords
Insomnia, Depression, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
678 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eszopiclone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
Eszopiclone 3 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Effexor
Intervention Description
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Primary Outcome Measure Information:
Title
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
Time Frame
Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of > 22 at the screening visit.
Exclusion Criteria:
Subjects who have a HAM-D-17 total score < 18 at Visit 2 will be discontinued from the study.
All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major Depressive Disorder.
Subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, CNS
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
City
Salzburg
Country
Austria
City
Wien
ZIP/Postal Code
A-1010
Country
Austria
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
City
Split
ZIP/Postal Code
21 000
Country
Croatia
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
City
Arcachon
Country
France
City
Caen
ZIP/Postal Code
14000
Country
France
City
Elancourt
ZIP/Postal Code
78990
Country
France
City
Le Pecq
ZIP/Postal Code
78230
Country
France
City
Rennes
ZIP/Postal Code
35000
Country
France
City
Savigny sur Orge
Country
France
City
Strasbourg
ZIP/Postal Code
67100
Country
France
City
Toulouse
ZIP/Postal Code
31000
Country
France
City
Toulouse
ZIP/Postal Code
31300
Country
France
City
Toulouse
Country
France
City
Verasailles
ZIP/Postal Code
78000
Country
France
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
City
Cegled
ZIP/Postal Code
2700
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4412
Country
Hungary
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
City
Bydgoszcz
Country
Poland
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
City
Lodz
ZIP/Postal Code
90-130
Country
Poland
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Tuszyn
ZIP/Postal Code
95-080
Country
Poland
City
Bucuresti
ZIP/Postal Code
041902
Country
Romania
City
Lasi
ZIP/Postal Code
700282
Country
Romania
City
Oradea
ZIP/Postal Code
410154
Country
Romania
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
City
Belchatow
ZIP/Postal Code
91-400
Country
Russian Federation
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
198020
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355108
Country
Russian Federation
City
Beograd
ZIP/Postal Code
11 000
Country
Serbia
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
City
NIS
ZIP/Postal Code
18000
Country
Serbia
City
NIS
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21 000
Country
Serbia
City
Donetsk
State/Province
Pobeda District
ZIP/Postal Code
83037
Country
Ukraine
City
Crimea
ZIP/Postal Code
95006
Country
Ukraine
City
Dnepropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
City
Kiev
ZIP/Postal Code
02660
Country
Ukraine
City
Kiev
ZIP/Postal Code
03049
Country
Ukraine
City
Kiev
ZIP/Postal Code
04080
Country
Ukraine
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
City
Odessa
ZIP/Postal Code
65000
Country
Ukraine
City
Vinnitsa
ZIP/Postal Code
21005
Country
Ukraine
City
Avon
State/Province
Bath
ZIP/Postal Code
BA 1 2SR
Country
United Kingdom
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
City
Coventry
Country
United Kingdom
City
Fowey
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 OXA
Country
United Kingdom
City
Harrow
ZIP/Postal Code
HA13UJ
Country
United Kingdom
City
Haywards Heath
ZIP/Postal Code
RH16 4BE
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL6 7TH
Country
United Kingdom
City
Warks
ZIP/Postal Code
CV32 4RA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
We'll reach out to this number within 24 hrs