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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435279
• Other study ID #: 190-062
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2007
• Last updated: February 21, 2012
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia and Montenegro: Agency for Drugs and Medicinal DevicesSerbia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insomnia
• Major Depressive Disorder

Intervention

Drug:
• Eszopiclone
Eszopiclone 3 mg
• Placebo
Placebo
• Venlafaxine
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

Austria,  Croatia,  France,  Hungary,  Poland,  Romania,  Russian Federation,  Serbia,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.		Week 8	Yes
Secondary	The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.		Week 1	Yes