Assessment of Cognitive Functioning Before and After Treatment With Duloxetine (DULOX)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Prabha Sunderajan, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00933439
First received: July 2, 2009
Last updated: August 9, 2013
Last verified: August 2013

July 2, 2009
August 9, 2013
February 2005
September 2007   (final data collection date for primary outcome measure)
Cognitive function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00933439 on ClinicalTrials.gov Archive Site
Psychosocial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Duloxetine
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.
Experimental: Duloxetine
Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933439
Duloxetine
No
Prabha Sunderajan, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Eli Lilly and Company
Principal Investigator: Prabha Sunderajan, MD UT Southwestern Medical Center - Department of Psychiatry
University of Texas Southwestern Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP