The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia related to major depressive disorder.
This study is a double-blind, randomized, placebo-controlled, parallel group study. The study consists of two groups of subjects with major depression treated for ten weeks with a common antidepressant regimen, 20-40 mg of fluoxetine hydrochloride per day; and randomized to receive (in addition) either eszopiclone 3 mg or placebo for eight weeks. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
545
Eszopiclone 3 mg QD
Placebo tablet
Mean subjective wake time after sleep onset (WASO)
Time frame: 1 week
Time to onset of 30% antidepressant response using the HAM-D-6 (Bech)
Mean WASO
Time frame: Weeks 2, 3, 4, 6 and 8
Mean subjective total sleep time (TST)
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Mean subjective sleep latency (SL)
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Mean number of awakenings
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Quality and depth of sleep
Time frame: Weeks 1, 2, 3, 4, 6 and 8
Daytime alertness
Time frame: Weeks 1, 2, 3, 4, 6 and 8
Ability to concentrate
Time frame: Weeks 1, 2, 3, 4, 6 and 8
Physical well-being
Time frame: Weeks 1, 2, 3, 4, 6 and 8
Ability to function
Time frame: Weeks 1, 2, 3, 4, 6, and 8
average rebound and withdrawal effects will be analyzed for each of the subjective sleep endpoints
Time frame: Weeks 1, 2, 3, 4, 6, and 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Fayetteville, Arkansas, United States
Unnamed facility
Garden Grove, California, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
Northridge, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Wheat Ridge, Colorado, United States
...and 55 more locations
Time to onset of 50% antidepressant response using the HAM-D-6 (Bech)
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Time to onset of 50% and 30% antidepressant responses using the HAM-D-6 (Maier)
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Change in the HAM-D-6 (Bech) and HAM-D-6 (Maier) from baseline to each visit
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Change in the HAM-D-17 from baseline
Time frame: Weeks 4 and 8
Symptom Questionnaire (SQ) Score (Depression Subscale)
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Daily Telephone Assessment (DTA) Score
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Change in HAM-D-6 (Bech), HAM-D-6 (Maier), HAM-D-17, SQ, and DTA during the wash-out phase until end of study
Time frame: Weeks 8 and 10
SF-36 Score
Time frame: Weeks 4, 8, and 10
Work Limitations Questionnaire (WLQ) Score
Time frame: Weeks 2, 4, 8, and 10
Epworth Sleepiness Scale (ESS)
Time frame: Weeks 1, 2, 3, 4, 6, 8, and 10
Insomnia Severity Index (ISI) score
Time frame: Weeks 2, 4, 8, and 10
Clinical Global Impression
Time frame: Weeks 1, 2, 3, 4, 6, 8, and 10
Safety will be assessed by physical examinations, a standard 12-lead ECG, vital signs, clinical laboratory assessments and AE reporting
Time frame: Weeks 1 through 10