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Sertraline vs. Venlafaxine XR

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sertraline
venlafaxine XR
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
June 1, 2015
Sponsor
Vanderbilt University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00179283
Brief Title
Sertraline vs. Venlafaxine XR
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Type
Drug
Intervention Name(s)
venlafaxine XR
Primary Outcome Measure Information:
Title
Ham-D (Hamilton Depression Rating Scale for Depression) 17-item
Title
Clinical Global Impression - Severity Scale
Title
Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Title
Treatment Emergent Symptom Scale-Revised (TESS-R)
Title
Brief Symptom Inventory (BSI)
Secondary Outcome Measure Information:
Title
NEO-5 factor Inventory (NEO-FFI)
Title
Anxiety Sensitivity Inventory (ASI)
Title
Mood Disorder Questionnaire (MDQ)
Title
Ham-A (Hamilton Rating Scale for Anxiety)
Title
Arizona Sexual Functioning Inventory (A-SEX)
Title
Atypical Features Inventory

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C Shelton, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17196045
Citation
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.
Results Reference
derived

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Sertraline vs. Venlafaxine XR

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