Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Texas Southwestern Medical Center
With
Eli Lilly and Company
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.
Age
18–45
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
