Major Depressive Disorder
Conditions
Keywords
Depression, Major Depressive Disorder, Cognitive Function, Psychosocial Function
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 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.
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 after treatment using cognitive tests. Eligible participants will have eight clinic visits.
Interventions
DRUGDuloxetine
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.
Sponsors
Eli Lilly and Company
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Psychosocial function | 8 weeks |
Countries
United States
Outcome results
None listed