Sertraline vs. Venlafaxine XR

NCT00179283

Last updated date
Study Location
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: sertraline
  • Drug: venlafaxine XR
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
 (submitted: September 13, 2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Richard C Shelton, MDVanderbilt University Medical Center
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