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CompletedNCT00179283Updated Jun 2, 2015

Sertraline vs. Venlafaxine XR

A Phase 3 interventional study of sertraline and venlafaxine XR in Major Depressive Disorder, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-02.

Sponsored by Vanderbilt University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
20 participants

Interventions

  • Drugsertraline
  • Drugvenlafaxine XR
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What researchers measure

Primary outcomes

  1. Ham-D (Hamilton Depression Rating Scale for Depression) 17-item

  2. Clinical Global Impression - Severity Scale

  3. Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  4. Treatment Emergent Symptom Scale-Revised (TESS-R)

  5. Brief Symptom Inventory (BSI)

Secondary outcomes

  1. NEO-5 factor Inventory (NEO-FFI)

  2. Anxiety Sensitivity Inventory (ASI)

  3. Mood Disorder Questionnaire (MDQ)

  4. Ham-A (Hamilton Rating Scale for Anxiety)

  5. Arizona Sexual Functioning Inventory (A-SEX)

  6. Atypical Features Inventory

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
08

References and documents

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. doi: 10.4088/jcp.v67n1102. PubMed 17196045 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00179283
Lead sponsor
Vanderbilt University
Collaborators
Pfizer
Responsible party
Richard C. Shelton (Director of Mood Disorders Clinic, Vanderbilt University) — Principal investigator
First posted
Sep 15, 2005
Start date
Apr 2002
Completion
Apr 2003
Last update
Jun 2, 2015

Study contacts

Richard C Shelton, MD
principal investigator · Vanderbilt University Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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