ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Sertraline vs. Venlafaxine XR | |||
Official Title ICMJE | A Multi-center, Randomized, Double-blind, Parallel-group Study of Sertraline vs. Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder | |||
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 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. | |||
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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Shelton RC, Haman KL, Rapaport MH, Kiev A, Smith WT, Hirschfeld RM, Lydiard RB, Zajecka JM, Dunner DL. A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder. J Clin Psychiatry. 2006 Nov;67(11):1674-81. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 20 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | April 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00179283 | |||
Other Study ID Numbers ICMJE | Sert-Ven | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Richard C. Shelton, Vanderbilt University | |||
Study Sponsor ICMJE | Vanderbilt University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Vanderbilt University | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |