Major Depressive DisorderDULOXNCT00933439
Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
A study testing Duloxetine in people with Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mood Disorders Research Program and Clinic - UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
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.
Read the 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
- Being tested
- Duloxetine
- Keywords
- Depression, Major Depressive Disorder, Cognitive Function, Psychosocial Function
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Not described Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Measured: 8 weeks
Secondary outcomes (1)
Psychosocial function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startFeb 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Prabha Sunderajan, University of Texas Southwestern Medical Center
- Investigators
- Prabha Sunderajan, MD, Principal investigator, UT Southwestern Medical Center - Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933439
- Sponsor's protocol ID
- Duloxetine
- Acronym
- DULOX
- Status last verified
- Aug 2013
- First submitted
- 2 Jul 2009
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24563781
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Functioning Before and After Treatment With Duloxetine
- ClinicalTrials.gov ID
- NCT00933439
- Acronym / sponsor ID
- DULOX / Duloxetine
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, Cognitive Function, Psychosocial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: Duloxetine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineApproximately 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. | Drug | Duloxetine |
Primary outcome
Cognitive function
Time frame: 8 weeks
1 secondary outcome
Psychosocial function
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Derived from this study: PubMed 24563781Greer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prabha Sunderajan, MD principal investigator
UT Southwestern Medical Center - Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.