A Study of Eszopiclone Co-Administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia

Condition(s) targeted: Major Depressive Disorder; Insomnia

Intervention: Eszopiclone (Drug); Placebo (Drug); Venlafaxine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sepracor, Inc.

Official(s) and/or principal investigator(s):
Medical Director, CNS, Study Chair, Affiliation: Sepracor, Inc.

Overall contact:
Sepracor Central Contact, Phone: 1-866-503-6351

To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.

Secondary outcome: The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.

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.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Sepracor Central Contact, Phone: 1-866-503-6351

Wien A-1090, Austria; Recruiting

Wien A-1010, Austria; Recruiting

Salzburg, Austria; Recruiting

Split 21 000, Croatia; Recruiting

Zagreb 10090, Croatia; Recruiting

Zagreb 10 000, Croatia; Recruiting

Rennes 35000, France; Recruiting

Toulouse 31300, France; Recruiting

Elancourt 78990, France; Recruiting

Caen 14000, France; Recruiting

Strasbourg 67100, France; Recruiting

Toulouse 31000, France; Recruiting

Le Pecq 78230, France; Recruiting

Verasailles 78000, France; Recruiting

Savigny sur Orge, France; Recruiting

Arcachon, France; Recruiting

Toulouse, France; Recruiting

Cegled 2700, Hungary; Recruiting

Balassagyarmat 2660, Hungary; Recruiting

Nyiregyhaza 4412, Hungary; Recruiting

Budapest 1135, Hungary; Recruiting

Budapest 1083, Hungary; Recruiting

Budapest 1134, Hungary; Recruiting

Torun 87-100, Poland; Recruiting

Krakow 31-530, Poland; Recruiting

Lodz 90-130, Poland; Recruiting

Lublin 20-109, Poland; Recruiting

Belchatow 97-400, Poland; Recruiting

Tuszyn 95-080, Poland; Recruiting

Bydgoszcz, Poland; Recruiting

Lasi 700282, Romania; Recruiting

Oradea 410154, Romania; Recruiting

Bucuresti 041902, Romania; Recruiting

Moscow 107076, Russian Federation; Recruiting

Moscow 125367, Russian Federation; Recruiting

St. Petersburg 190121, Russian Federation; Recruiting

St. Petersburg 192019, Russian Federation; Recruiting

Moscow 115522, Russian Federation; Recruiting

Stavropol 355108, Russian Federation; Recruiting

Belchatow 91-400, Russian Federation; Recruiting

Arkhangelsk 163001, Russian Federation; Recruiting

St. Petersburg 191180, Russian Federation; Recruiting

St. Petersburg 198020, Russian Federation; Recruiting

St. Petersburg 197341, Russian Federation; Recruiting

St. Petersburg 194044, Russian Federation; Withdrawn

Beograd 11 000, Serbia; Recruiting

Kragujevac 34 000, Serbia; Recruiting

Novi Sad 21 000, Serbia; Recruiting

Beograd 11000, Serbia; Recruiting

NIS 18000, Serbia; Recruiting

NIS, Serbia; Recruiting

Vinnitsa 21005, Ukraine; Not yet recruiting

Crimea 95006, Ukraine; Not yet recruiting

Odessa 65000, Ukraine; Not yet recruiting

Kiev 02660, Ukraine; Recruiting

Kiev 03049, Ukraine; Not yet recruiting

Lviv 79021, Ukraine; Recruiting

Kiev 04080, Ukraine; Recruiting

Dnepropetrovsk 49005, Ukraine; Recruiting

Haywards Heath RH16 4BE, United Kingdom; Not yet recruiting

Fowey PL23 1DT, United Kingdom; Not yet recruiting

Glasgow G20 OXA, United Kingdom; Not yet recruiting

Harrow HA13UJ, United Kingdom; Not yet recruiting

Plymouth PL6 7TH, United Kingdom; Recruiting

Coventry, United Kingdom; Recruiting

Warks CV32 4RA, United Kingdom; Recruiting

Avon, Bath BA 1 2SR, United Kingdom; Recruiting

Donetsk, Pobeda District 83037, Ukraine; Not yet recruiting

Glasgow, Scotland G51 4TF, United Kingdom; Not yet recruiting

Lunesta Patient Instructions for Use

Starting date: June 2007
Ending date: February 2009
Last updated: September 30, 2008