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

NCT ID: NCT00644982

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-09-30

Brief Summary

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

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sertaline group

Group Type EXPERIMENTAL

sertraline

Intervention Type DRUG

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

Venlafaxine group

Group Type ACTIVE_COMPARATOR

venlafaxine XR

Intervention Type DRUG

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

Interventions

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sertraline

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

Intervention Type DRUG

venlafaxine XR

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

Intervention Type DRUG

Other Intervention Names

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Zoloft

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cairns, Queensland, Australia

Site Status

Pfizer Investigational Site

Everton Park, Queensland, Australia

Site Status

Pfizer Investigational Site

North Cairns, Queensland, Australia

Site Status

Pfizer Investigational Site

Box Hill, Victoria, Australia

Site Status

Pfizer Investigational Site

Heidelberg, Victoria, Australia

Site Status

Pfizer Investigational Site

WEST Heidelberg, Victoria, Australia

Site Status

Pfizer Investigational Site

West Perth, Western Australia, Australia

Site Status

Pfizer Investigational Site

Adana, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Diyarbakır, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

İzmit, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Australia Turkey (Türkiye)

Related Links

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Other Identifiers

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A0501066

Identifier Type: -

Identifier Source: org_study_id

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