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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Disorder, Cognitive Function, Psychosocial Function

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mood Disorders Research Program and Clinic - UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

Outcomes

Primary Outcome Measures

Cognitive function

Secondary Outcome Measures

Psychosocial function

Full Information

First Posted
July 2, 2009
Last Updated
August 9, 2013
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00933439
Brief Title
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Acronym
DULOX
Official Title
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depressive Disorder, Cognitive Function, Psychosocial Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
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 Measure Information:
Title
Cognitive function
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Psychosocial function
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prabha Sunderajan, MD
Organizational Affiliation
UT Southwestern Medical Center - Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Research Program and Clinic - UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24563781
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.
Results Reference
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Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

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