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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Insomnia

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

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

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

Summary

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

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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. 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

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.

Locations and Contacts

Salzburg, Austria

Wien A-1010, Austria

Wien A-1090, Austria

Split 21 000, Croatia

Zagreb 10090, Croatia

Zagreb 10 000, Croatia

Arcachon, France

Caen 14000, France

Elancourt 78990, France

Le Pecq 78230, France

Rennes 35000, France

Savigny sur Orge, France

Strasbourg 67100, France

Toulouse 31000, France

Toulouse 31300, France

Toulouse, France

Verasailles 78000, France

Balassagyarmat 2660, Hungary

Budapest 1083, Hungary

Budapest 1134, Hungary

Budapest 1135, Hungary

Cegled 2700, Hungary

Nyiregyhaza 4412, Hungary

Belchatow 97-400, Poland

Bydgoszcz, Poland

Krakow 31-530, Poland

Lodz 90-130, Poland

Lublin 20-109, Poland

Torun 87-100, Poland

Tuszyn 95-080, Poland

Bucuresti 041902, Romania

Lasi 700282, Romania

Oradea 410154, Romania

Arkhangelsk 163001, Russian Federation

Belchatow 91-400, Russian Federation

Moscow 107076, Russian Federation

Moscow 115522, Russian Federation

Moscow 125367, Russian Federation

St. Petersburg 198020, Russian Federation

St. Petersburg 191180, Russian Federation

St. Petersburg 192019, Russian Federation

St. Petersburg 194044, Russian Federation

St. Petersburg 197341, Russian Federation

St. Petersburg 190121, Russian Federation

Stavropol 355108, Russian Federation

Beograd 11 000, Serbia

Beograd 11000, Serbia

Kragujevac 34 000, Serbia

NIS 18000, Serbia

NIS, Serbia

Novi Sad 21 000, Serbia

Crimea 95006, Ukraine

Dnepropetrovsk 49005, Ukraine

Kiev 02660, Ukraine

Kiev 03049, Ukraine

Kiev 04080, Ukraine

Lviv 79021, Ukraine

Odessa 65000, Ukraine

Vinnitsa 21005, Ukraine

Coventry, United Kingdom

Fowey PL23 1DT, United Kingdom

Glasgow G20 OXA, United Kingdom

Harrow HA13UJ, United Kingdom

Haywards Heath RH16 4BE, United Kingdom

Plymouth PL6 7TH, United Kingdom

Warks CV32 4RA, United Kingdom

Avon, Bath BA 1 2SR, United Kingdom

Donetsk, Pobeda District 83037, Ukraine

Glasgow, Scotland G51 4TF, United Kingdom

Additional Information

Starting date: June 2007
Last updated: February 21, 2012

Page last updated: August 23, 2015

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