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

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

Study Overview

• Status: Completed
• Conditions: Insomnia; Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Eszopiclone; Drug: Venlafaxine

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.

• Study Type: Interventional
• Enrollment (Actual): 678
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria
  • Wien, Austria, A-1010
  • Wien, Austria, A-1090
• Croatia
  • Split, Croatia, 21 000
  • Zagreb, Croatia, 10 000
  • Zagreb, Croatia, 10090
• France
  • Arcachon, France
  • Caen, France, 14000
  • Elancourt, France, 78990
  • Le Pecq, France, 78230
  • Rennes, France, 35000
  • Savigny sur Orge, France
  • Strasbourg, France, 67100
  • Toulouse, France, 31000
  • Toulouse, France, 31300
  • Toulouse, France
  • Verasailles, France, 78000
• Hungary
  • Balassagyarmat, Hungary, 2660
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1134
  • Budapest, Hungary, 1135
  • Cegled, Hungary, 2700
  • Nyiregyhaza, Hungary, 4412
• Poland
  • Belchatow, Poland, 97-400
  • Bydgoszcz, Poland
  • Krakow, Poland, 31-530
  • Lodz, Poland, 90-130
  • Lublin, Poland, 20-109
  • Torun, Poland, 87-100
  • Tuszyn, Poland, 95-080
• Romania
  • Bucuresti, Romania, 041902
  • Lasi, Romania, 700282
  • Oradea, Romania, 410154
• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
  • Belchatow, Russian Federation, 91-400
  • Moscow, Russian Federation, 115522
  • Moscow, Russian Federation, 107076
  • Moscow, Russian Federation, 125367
  • St. Petersburg, Russian Federation, 190121
  • St. Petersburg, Russian Federation, 191180
  • St. Petersburg, Russian Federation, 192019
  • St. Petersburg, Russian Federation, 194044
  • St. Petersburg, Russian Federation, 197341
  • St. Petersburg, Russian Federation, 198020
  • Stavropol, Russian Federation, 355108
• Serbia
  • Beograd, Serbia, 11 000
  • Beograd, Serbia, 11000
  • Kragujevac, Serbia, 34 000
  • NIS, Serbia, 18000
  • NIS, Serbia
  • Novi Sad, Serbia, 21 000
• Ukraine
  • Crimea, Ukraine, 95006
  • Dnepropetrovsk, Ukraine, 49005
  • Kiev, Ukraine, 02660
  • Kiev, Ukraine, 03049
  • Kiev, Ukraine, 04080
  • Lviv, Ukraine, 79021
  • Odessa, Ukraine, 65000
  • Vinnitsa, Ukraine, 21005
  • Pobeda District
    • Donetsk, Pobeda District, Ukraine, 83037
• United Kingdom
  • Coventry, United Kingdom
  • Fowey, United Kingdom, PL23 1DT
  • Glasgow, United Kingdom, G20 OXA
  • Harrow, United Kingdom, HA13UJ
  • Haywards Heath, United Kingdom, RH16 4BE
  • Plymouth, United Kingdom, PL6 7TH
  • Warks, United Kingdom, CV32 4RA
  • Bath
    • Avon, Bath, United Kingdom, BA 1 2SR
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Drug: Placebo; Placebo; Drug: Venlafaxine; Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28; Other Names: Effexor
Experimental: Eszopiclone	Drug: Eszopiclone; Eszopiclone 3 mg; Other Names: Lunesta; Drug: Venlafaxine; Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28; Other Names: Effexor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.	Week 1

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Study Chair: Medical Director, CNS, Sunovion

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 12, 2007
• First Submitted That Met QC Criteria: February 13, 2007
• First Posted (Estimate): February 14, 2007

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Depression; Insomnia; Major Depressive Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Disease; Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Hypnotics and Sedatives; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride; Eszopiclone
• Other Study ID Numbers: 190-062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No