Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

NCT ID: NCT00933439

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2007-09-30

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder; Cognitive Function; Psychosocial Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duloxetine

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Prabha Sunderajan

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prabha Sunderajan, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center - Department of Psychiatry

Locations

Mood Disorders Research Program and Clinic - UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24563781 (View on PubMed)

Other Identifiers

Duloxetine

Identifier Type: -

Identifier Source: org_study_id