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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00179257
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 2, 2015
Information provided by (Responsible Party):
Richard C. Shelton, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: sertraline (Zoloft) Phase 3

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 : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
Study Start Date : June 2004
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
  2. Hamilton Rating Scale for Depression (21-item) total score
  3. Clinical Global Impressions - Improvement Scale

Secondary Outcome Measures :
  1. Hamilton Anxiety Scale Total score
  2. Clinical Global Impressions - Severity Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00179257

Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Richard C Shelton, MD Vanderbilt University Medical Center

Responsible Party: Richard C. Shelton, Director of Mood Disorders Clinic, Vanderbilt University Identifier: NCT00179257     History of Changes
Other Study ID Numbers: Lexapro Failure Study
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Richard C. Shelton, Vanderbilt University:
Failure to Escitalopram

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents