Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Duloxetine

• Registration Number: NCT00933439
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	-

Primary Outcome Measures

Name	Time	Method
Cognitive function	8 weeks

Secondary Outcome Measures

Name	Time	Method
Psychosocial function	8 weeks

Trial Locations

Locations (1)

Mood Disorders Research Program and Clinic - UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States