Clinical Trials Directory

Trials / Completed

CompletedNCT00179257

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
20 (planned)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGsertraline (Zoloft)

Timeline

Start date
2004-06-01
Completion
2005-03-01
First posted
2005-09-15
Last updated
2015-06-02

Source: ClinicalTrials.gov record NCT00179257. Inclusion in this directory is not an endorsement.