Clinical Trial: Medications for the Treatment of Dysthymic Disorder and Double Depression

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression

Brief Summary: The purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.

Detailed Summary:

Dysthymic Disorder is a common, chronic type of depression that is often seen as a mild condition and is under-treated. Because of its chronic course, it is often complicated by episodes of major depression and may require long-term treatment.

This is a twelve week study during which daily doses of escitalopram (10-20 mg) or sertraline (50-200 mg) will be given to outpatients meeting criteria for Dysthymic Disorder or Double Depression. Medications will be assigned 1:1 and clinicians will be blinded to treatment. Efficacy will be based on scores for the Hamilton Depression Rating Scale, patient subjective reporting, and clinician observation. The study will have a total of 8 visits over 12 weeks, with a one-week medication taper period at the end. Subjects will have a physical exam, labs, and vital signs monitored at first visit and vital signs monitored at every subsequent visit. Women of childbearing potential must have a negative urine pregnancy test at screening. All subjects will remain on the lowest medication dose for the first four weeks of the study.

Sponsor: Oregon Health and Science University

Current Primary Outcome: score on first 17 items of HAM-D Rating Scale 24 item, each visit

Original Primary Outcome: Same as current

Current Secondary Outcome: scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)

Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: October 4, 2005
Date Started: September 2005
Date Completion: October 2006
Last Updated: September 7, 2006
Last Verified: September 2006