Sertraline vs. Venlafaxine XR

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00179283

Run by

Vanderbilt University

People needed

20

Starts

2002-04-01

Expected to finish

2003-04-01

Last updated by the study team

2015-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.