Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179257
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2005-09-13
Brief Title:
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 premature discontinuation because of side effects or the report of an incomplete response to escitalopram minimum dose 10mgday maintain for 3 weeks or more 10mgday was chosen because 1 it is the most commonly prescribed single dose of escitalopram in clinical practice 2 it is equivalent to approx 30mgday of arcemic citalopram and 3 escitalopram has very high potency at the serotonin transporter Ki11 this means that escitalopram would be expected to saturate the transporter at relatively low doses A total of twenty patients will be treated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None