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
  Purpose

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 Intervention
Major Depressive Disorder
Drug: Duloxetine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933439

Locations
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
Investigators
Principal Investigator: Prabha Sunderajan, MD UT Southwestern Medical Center - Department of Psychiatry
  More Information

No publications provided

Responsible Party: Prabha Sunderajan, Clinical Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00933439     History of Changes
Other Study ID Numbers: Duloxetine
Study First Received: July 2, 2009
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 16, 2014