Status:
COMPLETED
Sertraline vs. Venlafaxine XR
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00179283
Start Date
April 1 2002
End Date
April 1 2003
Last Update
June 2 2015
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212