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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by University of Texas Southwestern Medical Center.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT00933439

First received: July 2, 2009

Last updated: July 6, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 2, 2009

Last Updated Date

July 6, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Cognitive function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00933439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Psychosocial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

Official Title ^ICMJE

Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Duloxetine

Intervention: Drug: Duloxetine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00933439

Other Study ID Numbers ^ICMJE

Duloxetine

Has Data Monitoring Committee

Responsible Party

Prabha Sunderajan, MD, University of Texas Southwestern Medical Center - Department of Psychiatry

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Prabha Sunderajan, MD

UT Southwestern Medical Center - Department of Psychiatry

Information Provided By

University of Texas Southwestern Medical Center

Verification Date

July 2009

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

To Top