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Sponsors and Collaborators: |
Oregon Health and Science University Forest Laboratories |
Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00234312 |
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.
Condition | Intervention | Phase |
Depression Dysthymia |
Drug: escitalopram and sertraline |
Phase IV |
MedlinePlus related topics: | Depression |
ChemIDplus related topics: | Sertraline hydrochloride Sertraline Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Oregon | |||||
Oregon Health Sciences University | |||||
Portland, Oregon, United States, 97239 |
Oregon Health and Science University |
Forest Laboratories |
Principal Investigator: | Joshua Boverman, MD | Oregon Health and Science University |
Study ID Numbers: | 04-2801-A 02 |
First Received: | October 4, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00234312 |
Health Authority: | United States: Institutional Review Board |
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