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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Eszopiclone; Venlafaxine Hydrochloride

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.