NCT00179283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

June 2, 2015

Status Verified

June 1, 2015

First QC Date

September 13, 2005

Last Update Submit

June 1, 2015

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Interventions

sertralineDRUG
venlafaxine XRDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single or Recurrent Episode of MDD without psychotic features
  • Additional diagnoses will be permitted only if they are identified as secondary diagnoses
  • or above on 17-item Ham-D with item 1 (depressed mood) score of 2 or above

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • 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.

    PMID: 17196045DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Richard C Shelton, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Mood Disorders Clinic

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2002

Study Completion

April 1, 2003

Last Updated

June 2, 2015

Record last verified: 2015-06

Locations

US(1)