Status:
COMPLETED
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00179257
Start Date
June 1 2004
End Date
March 1 2005
Last Update
June 2 2015
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