Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234312
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2005-10-04
Brief Title:
Medications for the Treatment of Dysthymic Disorder and Double Depression
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Escitalopram vs Sertraline in the Treatment of Dysthymic Disorder and Double Depression
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None