- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179257
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
June 1, 2015 updated by: Richard C. Shelton, Vanderbilt University
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
20
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Hamilton Anxiety Scale Total score
|
Clinical Global Impressions - Severity Scale
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
June 2, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- Lexapro Failure Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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