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
| Type | Name | Description |
|---|---|---|
| DRUG | sertraline (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.