A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
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
1 other identifier
interventional
678
10 countries
69
Brief Summary
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Jun 2007
Typical duration for phase_3 major-depressive-disorder
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFebruary 22, 2012
February 1, 2012
2.1 years
February 12, 2007
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
Week 8
Secondary Outcomes (1)
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
Week 1
Study Arms (2)
Eszopiclone
EXPERIMENTALPlacebo
EXPERIMENTALInterventions
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Unknown Facility
Salzburg, Austria
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Vienna, A-1010, Austria
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Vienna, A-1090, Austria
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Split, 21 000, Croatia
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Zagreb, 10 000, Croatia
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Zagreb, 10090, Croatia
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Arcachon, France
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Caen, 14000, France
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Élancourt, 78990, France
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Le Pecq, 78230, France
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Rennes, 35000, France
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Savigny-sur-Orge, France
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Strasbourg, 67100, France
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Toulouse, 31000, France
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Toulouse, 31300, France
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Toulouse, France
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Verasailles, 78000, France
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Balassagyarmat, 2660, Hungary
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Budapest, 1083, Hungary
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Budapest, 1134, Hungary
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Budapest, 1135, Hungary
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Cegléd, 2700, Hungary
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Nyíregyháza, 4412, Hungary
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Bełchatów, 97-400, Poland
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Bydgoszcz, Poland
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Krakow, 31-530, Poland
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Lodz, 90-130, Poland
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Lublin, 20-109, Poland
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Torun, 87-100, Poland
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Tuszyn, 95-080, Poland
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Bucharest, 041902, Romania
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Lasi, 700282, Romania
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Oradea, 410154, Romania
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Arkhangelsk, 163001, Russia
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Belchatow, 91-400, Russia
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Moscow, 107076, Russia
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Moscow, 115522, Russia
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Moscow, 125367, Russia
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Saint Petersburg, 190121, Russia
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Saint Petersburg, 191180, Russia
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Saint Petersburg, 192019, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 197341, Russia
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Saint Petersburg, 198020, Russia
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Stavropol, 355108, Russia
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Belgrade, 11 000, Serbia
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Belgrade, 11000, Serbia
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Kragujevac, 34 000, Serbia
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Niš, 18000, Serbia
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Niš, Serbia
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Novi Sad, 21 000, Serbia
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Donetsk, Pobeda District, 83037, Ukraine
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Crimea, 95006, Ukraine
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Dnipro, 49005, Ukraine
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Kiev, 02660, Ukraine
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Kiev, 03049, Ukraine
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Kiev, 04080, Ukraine
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Lviv, 79021, Ukraine
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Odesa, 65000, Ukraine
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Vinnitsa, 21005, Ukraine
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Avon, Bath, BA 1 2SR, United Kingdom
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Glasgow, Scotland, G51 4TF, United Kingdom
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Coventry, United Kingdom
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Fowey, PL23 1DT, United Kingdom
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Glasgow, G20 OXA, United Kingdom
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Harrow, HA13UJ, United Kingdom
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Haywards Heath, RH16 4BE, United Kingdom
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Plymouth, PL6 7TH, United Kingdom
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Warks, CV32 4RA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Medical Director, CNS
Sumitomo Pharma America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 14, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 22, 2012
Record last verified: 2012-02