Sertraline vs. Venlafaxine XR

June 1, 2015 updated by: Richard C. Shelton, Vanderbilt University

A Multi-center, Randomized, Double-blind, Parallel-group Study of Sertraline vs. Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder

This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline vs. venlafaxine Extended Release in the acute treatment of Major Depression in male and female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated randomized list.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline vs. venlafaxine XR in the acute treatment of Major Depression in male and female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated randomized list.

The primary objectives of the study are: to assess the comparative safety and tolerability of sertraline and venlafaxine XR and to assess number and severity of discontinuation symptoms and time to termination of taper at the end of acute treatment with sertraline vs. venlafaxine XR.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single or Recurrent Episode of MDD without psychotic features
  • Additional diagnoses will be permitted only if they are identified as secondary diagnoses
  • 18 or above on 17-item Ham-D with item 1 (depressed mood) score of 2 or above

Exclusion Criteria:

  • Current or past diagnosis of Bipolar Disorder
  • Any history or current psychotic disorder
  • Current psychotic symptoms, including current delusional depression
  • Current diagnosis of delirium or dementia
  • Alcohol or drug abuse or dependence in last 6 months or currently
  • Schizoid, Schizotypal, or Borderline Personality Disorder
  • Non-response to sertraline at least 150mg for 4 weeks or more, venlafaxine XR at least 225mg for 4 weeks or more, or non-response to 2 antidepressants in the current episode
  • Use of any antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
  • Use of herbal and/or homeopathic remedies concomitantly or within 2 weeks of baseline excluding vitamins and mineral supplements
  • Use within 1 week of baseline or concomitant use of any psychotropics with the exception zolpidem or zopiclone PRN for sleep
  • Use within 4 weeks of baseline of benzodiazepines taken on a regular, daily basis (PRN use is acceptable as long as none in week leading up to randomization)
  • Score of 3 or 4 on the suicide item, item 3 of the Ham-D scale at screen or baseline visit
  • Participation in any other studies concomitantly or within 90 days prior to entry into this study
  • Treatment with monoamine oxidase inhibitors within 14 days of baseline
  • Treatment of electroconvulsive therapy within 30 days of baseline
  • Previous history or intolerance or hypersensitivity and/or venlafaxine XR
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  • Presence of serious and/or unstable medical condition
  • Abnormal laboratory results
  • Positive pregnancy test and/or nursing women or fertile women not practicing an effective method of birth control
  • History seizure disorder-excluding febrile seizures of childhood
  • Any other condition which in the investigator's judgement might increase the risk to the subject or decrease the chance of obtaining satisfactory data
  • Mental condition rendering the subject unable to understand the procedures
  • Unable and/or unlikely to comprehend and/or follow the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ham-D (Hamilton Depression Rating Scale for Depression) 17-item
Clinical Global Impression - Severity Scale
Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Treatment Emergent Symptom Scale-Revised (TESS-R)
Brief Symptom Inventory (BSI)

Secondary Outcome Measures

Outcome Measure
NEO-5 factor Inventory (NEO-FFI)
Anxiety Sensitivity Inventory (ASI)
Mood Disorder Questionnaire (MDQ)
Ham-A (Hamilton Rating Scale for Anxiety)
Arizona Sexual Functioning Inventory (A-SEX)
Atypical Features Inventory

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sert-Ven

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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