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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Pfizer
• Treatments: Citalopram; Dexetimide; Sertraline

Criteria

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