Clinical trial NCT00644982: A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
Official title: A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses.
* Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score ≥2.

Exclusion Criteria:

* Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
* Current or past diagnosis of bipolar disorder or any psychotic disorder.

Primary outcomes:
measure: Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcomes:
measure: 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.
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
measure: The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
timeFrame: Week 8
measure: CGI response rate at endpoint (week 8).
timeFrame: Week 8
measure: Change from baseline in the CGI-Severity Scale (CGI-S).
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
measure: Change from baseline in the Hamilton Anxiety Scale (HAM-A).
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
measure: Change from baseline in the Endicott Work Productivity Scale (EWPS).
timeFrame: Weeks 1, 8, 9, 10
measure: Change from baseline in the Visual Analogue Scale (VAS) for Depression.
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
measure: Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
timeFrame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
measure: Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
timeFrame: Week 8
measure: Change from baseline in the Clinical Global Impression-Improvement Scale.
timeFrame: Weeks 1, 2, 3, 4, 6, 8
Other outcomes:
Locations:
city: Cairns
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Everton Park
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: North Cairns
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Box Hill
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: WEST Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: West Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Adana
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Diyarbakir
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Izmit
country: Turkey
facility: Pfizer Investigational Site
city: Malatya
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: