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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eli Lilly and Company | INDUSTRY |
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The following primary hypotheses will be tested:
This is a two-part study. Step 1 is an 8-week long open-label trial of duloxetine (DUL) + clinical management (CM), titrated up to 90 mg/day, for older adults with comorbid major depressive disorder (MDD) and chronic low back pain (CLBP). At week 8, if subjects have not responded, the dose of duloxetine is increased to 120 mg/day. Duloxetine will be increased and continued at 120 mg/day (or highest tolerated dose) for both randomized study groups (during step 2) to assure medication parity.
Step two starts at week 9 and includes those subjects whose MDD and/or CLBP has not met criteria for response during Step 1. At week 9 subjects will be randomized to receive treatment with either: 1) DUL 120 mg/day (or the highest tolerated dose)+ Problem Solving for Depression and Pain (PST-DP) or 2) DUL 120 mg/day (or highest tolerated dose) + CM. Step 2 will be delivered over the course of 8-10 sessions.
NOTE ADDED 1/5/16: THIS WAS TREATMENT DEVELOPMENT WORK CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. ONLY THE FIRST OPEN-LABEL PART OF THE STUDY WAS COMPLETED, AND THESE RESULTS HAVE BEEN PUBLISHED AND WILL BE REPORTED HERE ON CLINICALTRIALS.GOV
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Duloxetine + clinical management NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Duloxetine up to 120 mg/day + Clinical Management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks | The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome Larger reduction between MADRS from baseline to 12 weeks would represent better outcome | baseline and 12 weeks |
| Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks | The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe). A larger reduction of the score from baseline to 12 weeks would represent a better outcome | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan F Karp, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19750557 | Result | Karp JF, Weiner DK, Dew MA, Begley A, Miller MD, Reynolds CF 3rd. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study. Int J Geriatr Psychiatry. 2010 Jun;25(6):633-42. doi: 10.1002/gps.2386. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine Plus Clinical Management | Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine Plus Clinical Management | Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks | The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome Larger reduction between MADRS from baseline to 12 weeks would represent better outcome | description of median change | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine Plus Clinical Management | Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan F. Karp, MD | University of Pittsburgh | 412-246-6048 | karpjf@upmc.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks | The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe). A larger reduction of the score from baseline to 12 weeks would represent a better outcome | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |