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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179257
First received: September 13, 2005
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: sertraline (Zoloft)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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

Estimated Enrollment: 20
Study Start Date: June 2004
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179257

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

ClinicalTrials.gov Identifier: NCT00179257     History of Changes
Other Study ID Numbers: Lexapro Failure Study
Study First Received: September 13, 2005
Last Updated: September 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Failure to Escitalopram

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
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

ClinicalTrials.gov processed this record on October 19, 2014