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The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sertraline (Zoloft)
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Failure to Escitalopram

Eligibility Criteria

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

Inclusion Criteria: Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses Ham-D 21 item score of greater than or equal to 18 Age 18 and above Ability and willingness to provide consent for participation Failure to respond to escitalopram Exclusion Criteria: Diagnosis of Bipolar Disorder or any psychotic disorder Alcohol or drug abuse or dependence currently or in the last 6 months A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine) Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent Presence of serious and/or unstable medical condition Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale Known sensitivity of sertraline

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
    Hamilton Rating Scale for Depression (21-item) total score
    Clinical Global Impressions - Improvement Scale

    Secondary Outcome Measures

    Hamilton Anxiety Scale Total score
    Clinical Global Impressions - Severity Scale

    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
    NCT00179257
    Brief Title
    The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
    Official Title
    The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2005 (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
    The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram.
    Detailed Description
    Eight week open-label flexible dose trial in adult outpatients diagnosed with Major Depressive Disorder (MDD) who have had a prior failure with escitalopram. Failure is operationally defined as either premature discontinuation because of side effects or the report of an incomplete response to escitalopram, minimum dose 10mg/day, maintain for 3 weeks or more. 10mg/day was chosen because 1) it is the most commonly prescribed single dose of escitalopram in clinical practice, 2) it is equivalent to approx. 30mg/day of arcemic citalopram and 3) escitalopram has very high potency at the serotonin transporter (Ki=1.1); this means that escitalopram would be expected to saturate the transporter at relatively low doses. A total of twenty patients will be treated.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    sertraline (Zoloft)
    Primary Outcome Measure Information:
    Title
    Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
    Title
    Hamilton Rating Scale for Depression (21-item) total score
    Title
    Clinical Global Impressions - Improvement Scale
    Secondary Outcome Measure Information:
    Title
    Hamilton Anxiety Scale Total score
    Title
    Clinical Global Impressions - Severity Scale

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses Ham-D 21 item score of greater than or equal to 18 Age 18 and above Ability and willingness to provide consent for participation Failure to respond to escitalopram Exclusion Criteria: Diagnosis of Bipolar Disorder or any psychotic disorder Alcohol or drug abuse or dependence currently or in the last 6 months A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine) Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent Presence of serious and/or unstable medical condition Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale Known sensitivity of sertraline
    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

    12. IPD Sharing Statement

    Learn more about this trial

    The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram

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