Clinical trial NCT00933439: Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Official title: Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Cognitive Function
Psychosocial Function
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive function
timeFrame: 8 weeks
Secondary outcomes:
measure: Psychosocial function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Mood Disorders Research Program and Clinic - UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center - Department of Psychiatry
name: Prabha Sunderajan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greer TL, Sunderajan P, Grannemann BD, Kurian BT, Trivedi MH. Does duloxetine improve cognitive function independently of its antidepressant effect in patients with major depressive disorder and subjective reports of cognitive dysfunction? Depress Res Treat. 2014;2014:627863. doi: 10.1155/2014/627863. Epub 2014 Jan 19.