Clinical trial NCT00435279: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Insomnia
Keywords: Insomnia
Depression
Major Depressive Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-14
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
timeFrame: Week 8
Secondary outcomes:
measure: The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
timeFrame: Week 1
Other outcomes:
Locations:
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Arcachon
country: France
city: Caen
country: France
city: Elancourt
country: France
city: Le Pecq
country: France
city: Rennes
country: France
city: Savigny sur Orge
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Verasailles
country: France
city: Balassagyarmat
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Cegled
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Belchatow
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Torun
country: Poland
city: Tuszyn
country: Poland
city: Bucuresti
country: Romania
city: Lasi
country: Romania
city: Oradea
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Belchatow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Beograd
country: Serbia
city: Beograd
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
city: NIS
country: Serbia
city: Novi Sad
country: Serbia
city: Donetsk
country: Ukraine
state: Pobeda District
city: Crimea
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Avon
country: United Kingdom
state: Bath
city: Glasgow
country: United Kingdom
state: Scotland
city: Coventry
country: United Kingdom
city: Fowey
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrow
country: United Kingdom
city: Haywards Heath
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Warks
country: United Kingdom
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, CNS
role: STUDY_CHAIR
References: