To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
Pfizer Investigational Site
Cairns, Queensland, Australia
Pfizer Investigational Site
Everton Park, Queensland, Australia
Pfizer Investigational Site
North Cairns, Queensland, Australia
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (≥50% reduction in HAM-D total score from baseline) and remission (HAM-D total score ≤7) rates.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
Time frame: Week 8
CGI response rate at endpoint (week 8).
Time frame: Week 8
Change from baseline in the CGI-Severity Scale (CGI-S).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Hamilton Anxiety Scale (HAM-A).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Endicott Work Productivity Scale (EWPS).
Time frame: Weeks 1, 8, 9, 10
Change from baseline in the Visual Analogue Scale (VAS) for Depression.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
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Pfizer Investigational Site
Box Hill, Victoria, Australia
Pfizer Investigational Site
Heidelberg, Victoria, Australia
Pfizer Investigational Site
WEST Heidelberg, Victoria, Australia
Pfizer Investigational Site
West Perth, Western Australia, Australia
Pfizer Investigational Site
Adana, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, Turkey (Türkiye)
Pfizer Investigational Site
Diyarbakır, Turkey (Türkiye)
...and 4 more locations
Time frame: Week 8
Change from baseline in the Clinical Global Impression-Improvement Scale.
Time frame: Weeks 1, 2, 3, 4, 6, 8