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

NCT00179257

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
Official Title  ICMJE The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: sertraline (Zoloft)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00179257
Other Study ID Numbers  ICMJE Lexapro Failure Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard C. Shelton, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Richard C Shelton, MDVanderbilt University Medical Center
PRS Account Vanderbilt University
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP