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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933439
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : August 13, 2013
Eli Lilly and Company
Information provided by (Responsible Party):
Prabha Sunderajan, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Study Start Date : February 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Duloxetine 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.

Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Psychosocial function [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00933439

United States, Texas
Mood Disorders Research Program and Clinic - UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Eli Lilly and Company
Principal Investigator: Prabha Sunderajan, MD UT Southwestern Medical Center - Department of Psychiatry

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prabha Sunderajan, Clinical Assistant Professor, University of Texas Southwestern Medical Center Identifier: NCT00933439     History of Changes
Other Study ID Numbers: Duloxetine
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Prabha Sunderajan, University of Texas Southwestern Medical Center:
Major Depressive Disorder
Cognitive Function
Psychosocial Function

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents