Clincosm LogoSign in Get a demo

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

Sponsor
Sunovion (Industry)
Overall Status
Completed
CT.gov ID
NCT00435279
Collaborator
(none)
678
Enrollment
69
Locations
2
Arms
25
Duration (Months)
9.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Jun 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. [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. [Week 1]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salzburg Austria
    2 Wien Austria A-1010
    3 Wien Austria A-1090
    4 Split Croatia 21 000
    5 Zagreb Croatia 10 000
    6 Zagreb Croatia 10090
    7 Arcachon France
    8 Caen France 14000
    9 Elancourt France 78990
    10 Le Pecq France 78230
    11 Rennes France 35000
    12 Savigny sur Orge France
    13 Strasbourg France 67100
    14 Toulouse France 31000
    15 Toulouse France 31300
    16 Toulouse France
    17 Verasailles France 78000
    18 Balassagyarmat Hungary 2660
    19 Budapest Hungary 1083
    20 Budapest Hungary 1134
    21 Budapest Hungary 1135
    22 Cegled Hungary 2700
    23 Nyiregyhaza Hungary 4412
    24 Belchatow Poland 97-400
    25 Bydgoszcz Poland
    26 Krakow Poland 31-530
    27 Lodz Poland 90-130
    28 Lublin Poland 20-109
    29 Torun Poland 87-100
    30 Tuszyn Poland 95-080
    31 Bucuresti Romania 041902
    32 Lasi Romania 700282
    33 Oradea Romania 410154
    34 Arkhangelsk Russian Federation 163001
    35 Belchatow Russian Federation 91-400
    36 Moscow Russian Federation 107076
    37 Moscow Russian Federation 115522
    38 Moscow Russian Federation 125367
    39 St. Petersburg Russian Federation 190121
    40 St. Petersburg Russian Federation 191180
    41 St. Petersburg Russian Federation 192019
    42 St. Petersburg Russian Federation 194044
    43 St. Petersburg Russian Federation 197341
    44 St. Petersburg Russian Federation 198020
    45 Stavropol Russian Federation 355108
    46 Beograd Serbia 11 000
    47 Beograd Serbia 11000
    48 Kragujevac Serbia 34 000
    49 NIS Serbia 18000
    50 NIS Serbia
    51 Novi Sad Serbia 21 000
    52 Donetsk Pobeda District Ukraine 83037
    53 Crimea Ukraine 95006
    54 Dnepropetrovsk Ukraine 49005
    55 Kiev Ukraine 02660
    56 Kiev Ukraine 03049
    57 Kiev Ukraine 04080
    58 Lviv Ukraine 79021
    59 Odessa Ukraine 65000
    60 Vinnitsa Ukraine 21005
    61 Avon Bath United Kingdom BA 1 2SR
    62 Glasgow Scotland United Kingdom G51 4TF
    63 Coventry United Kingdom
    64 Fowey United Kingdom PL23 1DT
    65 Glasgow United Kingdom G20 OXA
    66 Harrow United Kingdom HA13UJ
    67 Haywards Heath United Kingdom RH16 4BE
    68 Plymouth United Kingdom PL6 7TH
    69 Warks United Kingdom CV32 4RA

    Sponsors and Collaborators

    • Sunovion

    Investigators

    • Study Chair: Medical Director, CNS, Sunovion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT00435279
    Other Study ID Numbers:
    • 190-062
    First Posted:
    Feb 14, 2007
    Last Update Posted:
    Feb 22, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Sunovion
    Insomnia
    Depression
    Major Depressive Disorder
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Disease
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Eszopiclone
    Venlafaxine Hydrochloride

    Study Results

    No Results Posted as of Feb 22, 2012