Sertraline vs. Venlafaxine XR

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Pfizer
• Treatments: Sertraline; Venlafaxine Hydrochloride

Criteria

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