A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
NCT ID: NCT00435279
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
678 participants
INTERVENTIONAL
2007-06-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eszopiclone
Eszopiclone
Eszopiclone 3 mg
Venlafaxine
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Placebo
Placebo
Placebo
Venlafaxine
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Interventions
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Eszopiclone
Eszopiclone 3 mg
Placebo
Placebo
Venlafaxine
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, CNS
Role: STUDY_CHAIR
Sumitomo Pharma America, Inc.
Locations
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Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Split, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Arcachon, , France
Caen, , France
Élancourt, , France
Le Pecq, , France
Rennes, , France
Savigny-sur-Orge, , France
Strasbourg, , France
Toulouse, , France
Toulouse, , France
Toulouse, , France
Verasailles, , France
Balassagyarmat, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Cegléd, , Hungary
Nyíregyháza, , Hungary
Bełchatów, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Torun, , Poland
Tuszyn, , Poland
Bucharest, , Romania
Lasi, , Romania
Oradea, , Romania
Arkhangelsk, , Russia
Belchatow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Donetsk, Pobeda District, Ukraine
Crimea, , Ukraine
Dnipro, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnitsa, , Ukraine
Avon, Bath, United Kingdom
Glasgow, Scotland, United Kingdom
Coventry, , United Kingdom
Fowey, , United Kingdom
Glasgow, , United Kingdom
Harrow, , United Kingdom
Haywards Heath, , United Kingdom
Plymouth, , United Kingdom
Warks, , United Kingdom
Countries
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Other Identifiers
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190-062
Identifier Type: -
Identifier Source: org_study_id
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