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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00435279
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Sunovion

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Insomnia Drug: Eszopiclone Drug: Placebo Drug: Venlafaxine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eszopiclone Drug: Eszopiclone
Eszopiclone 3 mg
Other Name: Lunesta

Drug: Venlafaxine
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Other Name: Effexor

Experimental: Placebo Drug: Placebo
Placebo

Drug: Venlafaxine
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Other Name: Effexor




Primary Outcome Measures :
  1. The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. [ Time Frame: Week 8 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435279


Locations
Show Show 69 study locations
Sponsors and Collaborators
Sunovion
Investigators
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Study Chair: Medical Director, CNS Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00435279    
Other Study ID Numbers: 190-062
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Sunovion:
Insomnia
Depression
Major Depressive Disorder
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Eszopiclone
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Hypnotics and Sedatives
Central Nervous System Depressants