Sertraline vs. Venlafaxine XR - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	Pfizer
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179283

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:

MedlinePlus related topics: Anxiety Depression

Drug Information available for: Sertraline hydrochloride Sertraline Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

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

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):

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.

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:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Venlafaxine
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 24, 2012