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

Viatris

Status and phase: Completed; Phase 4

Conditions: Depressive Disorder, Major

Treatments: Drug: sertraline; Drug: venlafaxine XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644982

A0501066

Details and patient eligibility

About

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

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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163 participants in 2 patient groups

Sertaline group

Experimental group

Treatment:

Drug: sertraline

Venlafaxine group

Active Comparator group

Treatment:

Drug: venlafaxine XR