Medications for the Treatment of Dysthymic Disorder and Double Depression
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression|
- score on first 17 items of HAM-D Rating Scale 24 item, each visit
- scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||October 2006|
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.
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Joshua Boverman, MD||Oregon Health and Science University|