A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression

A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644982

Enrollment

163

Registered

2008-03-27

Start date

2002-10-31

Completion date

2003-09-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Brief summary

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

Interventions

DRUGsertraline

Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.

DRUGvenlafaxine XR

Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).	Weeks 1, 2, 3, 4, 6, 8, 9 and 10.

Secondary

Measure	Time frame
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).	Week 8
CGI response rate at endpoint (week 8).	Week 8
Change from baseline in the CGI-Severity Scale (CGI-S).	Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Hamilton Anxiety Scale (HAM-A).	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.	Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Visual Analogue Scale (VAS) for Depression.	Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.	Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).	Week 8
Change from baseline in the Clinical Global Impression-Improvement Scale.	Weeks 1, 2, 3, 4, 6, 8
Change from baseline in the Endicott Work Productivity Scale (EWPS).	Weeks 1, 8, 9, 10

Countries

Australia, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026