NCT00933439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

July 2, 2009

Last Update Submit

August 9, 2013

Conditions

Major Depressive Disorder

Keywords

DepressionMajor Depressive DisorderCognitive FunctionPsychosocial Function

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    8 weeks

Secondary Outcomes (1)

  • Psychosocial function

    8 weeks

Study Arms (1)

Duloxetine

EXPERIMENTAL
Drug: Duloxetine

Interventions

DuloxetineDRUG

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.

Duloxetine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mood Disorders Research Program and Clinic - UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

    PMID: 24563781DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Prabha Sunderajan, MD

    UT Southwestern Medical Center - Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

February 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

US(1)