Status:
COMPLETED
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 af...
Eligibility Criteria
Inclusion
- Ability and willingness to provide written informed consent
- Primary diagnosis of Major Depressive Disorder (MDD)
- Age 18-45
- Screening and baseline Hamilton Rating Scale for Depression (HRSD) 17-item score greater than or equal to 16 or Clinical Global Impression (CGI) score of at least 4
- Subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the Inventory for Depressive Symptomatology (IDS-C(30)) item addressing this symptom (#16: Concentration and Decision Making)
Exclusion
- Presence of significant comorbid condition based on laboratory tests, physician information, or evidence at examination
- Patient report or evidence (based on physical examination or laboratory tests) of existing liver disease
- Presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of duloxetine
- Concomitant pharmacological or psychotherapeutic treatment including but not limited to antidepressants, anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with duloxetine, as determined by the study doctor
- Hospitalization for mental illness within the past year
- Not fluent in spoken and written English
- For women, currently pregnant, planning to become pregnant in the next year, or breastfeeding
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00933439
Start Date
February 1 2005
End Date
September 1 2007
Last Update
August 13 2013
Active Locations (1)
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1
Mood Disorders Research Program and Clinic - UT Southwestern Medical Center
Dallas, Texas, United States, 75390