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Sertraline vs. Venlafaxine XR

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179283
First received: September 13, 2005
Last updated: April 6, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: sertraline
Drug: venlafaxine XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study of Sertraline vs. Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Ham-D (Hamilton Depression Rating Scale for Depression) 17-item
  • Clinical Global Impression - Severity Scale
  • Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
  • Treatment Emergent Symptom Scale-Revised (TESS-R)
  • Brief Symptom Inventory (BSI)

Secondary Outcome Measures:
  • NEO-5 factor Inventory (NEO-FFI)
  • Anxiety Sensitivity Inventory (ASI)
  • Mood Disorder Questionnaire (MDQ)
  • Ham-A (Hamilton Rating Scale for Anxiety)
  • Arizona Sexual Functioning Inventory (A-SEX)
  • Atypical Features Inventory

Estimated Enrollment: 20
Study Start Date: April 2002
Estimated Study Completion Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179283

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Pfizer
Investigators
Principal Investigator: Richard C Shelton, MD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00179283     History of Changes
Other Study ID Numbers: Sert-Ven
Study First Received: September 13, 2005
Last Updated: April 6, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Sertraline
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014