Status:
COMPLETED
A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Major Depressive Disorder
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).
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 eszopiclon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT00435279
Start Date
June 1 2007
End Date
July 1 2009
Last Update
February 22 2012
Active Locations (69)
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1
Salzburg, Austria
2
Vienna, Austria, A-1010
3
Vienna, Austria, A-1090
4
Split, Croatia, 21 000