Assessment of Cognitive Functioning Before and After Treatment With Duloxetine - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received: July 2, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00933439

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:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:

Arms	Assigned Interventions
Duloxetine: Experimental	Drug: Duloxetine Approximately 60 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 MDD
Age 18-45
Screening and baseline HRSD 17-item score greater than or equal to 16 or CGI score of at least 4
Subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the 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

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

Investigators

Principal Investigator:

Prabha Sunderajan, MD

UT Southwestern Medical Center - Department of Psychiatry

More Information

No publications provided

Responsible Party:	University of Texas Southwestern Medical Center - Department of Psychiatry ( Prabha Sunderajan, MD )
Study ID Numbers:	Duloxetine
Study First Received:	July 2, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933439 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Depression
Major Depressive Disorder
Cognitive Function
Psychosocial Function

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 10, 2009