Assessment of Cognitive Functioning Before and After Treatment With Duloxetine (DULOX)
The purpose of this study is to study the effect of duloxetine treatment on (1) cognitive functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering; (2) psychosocial functions, how someone interacts with his/her social environment; and (3) the relationship between these two functions, in people who have major depressive disorder, a severe form of depression.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of Cognitive Functioning Before and After Treatment With Duloxetine|
- Cognitive function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Psychosocial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Approximately 30 participants with major depressive disorder and concentration and/or cognition difficulties, recruited from the community and physician referrals, will be treated with duloxetine for 12 weeks. Their cognitive performance will be assessed pre- and post-treatment with a cognitive testing battery.
People who have difficulties with concentration and/or cognition as part of their depression will be treated with duloxetine for 12 weeks and their cognitive performance will be assessed before and after treatment using cognitive tests. Eligible participants will have eight clinic visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933439
|United States, Texas|
|Mood Disorders Research Program and Clinic - UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Prabha Sunderajan, MD||UT Southwestern Medical Center - Department of Psychiatry|