Major Depressive DisorderPhase 4ACHIEVE2NCT00696293
Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
A Phase 4 study testing Duloxetine in people with Major Depressive Disorder and Back Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
The following primary hypotheses will be tested: 1. During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in < 40% of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM) during the first 8 weeks will respond (response is defined as a Montgomery Asberg Depression… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder, Back Pain, Aged
- 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
- May 2007to Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 60
- Current episode of MDD per SCID DSM-IV criteria
- Must score >/= 16 on the CES-D assessment
- Serum sodium >/=130 mEq/ml
- CLBP of at least moderate severity for more days than not for >/= 3 months
- MADRS score >/= 15
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- Sufficiently medically stable to be able to participate in a depression treatment protocol
- Willingness and ability to speak English Access to translators is limited. It would be unsafe to treat an older adult who does not speak English with an antidepressant and not be able to effectively communicate with them about their progress and any side effects. We provide a 24/7 on-call service for all subjects enrolled in this study. The on-call clinicians and physicians are not bilingual, and if a problem arose, it may be impossible to effectively interpret and manage the emergent situation. Finally, many of the assessments used in the study are self-reports. At the present time, we do not have the ability to translate these instruments into other languages. If the subject cannot read and understand English, this would interfere with their ability to complete the self-report assessments
- Willingness to discontinue other antidepressants and anxiolytics, except for lorazepam up to 2 mg/day
- Mini Mental State Exam > 20
- Willingness to provide informed consent
- Corrected visual ability that enables reading of newspaper headlines and hearing capacity that is adequate to respond to a raised conversational voice.
Who cannot join
- Meet DSM-IV criteria for dementia
- History of bipolar, schizophrenia, schizoaffective, or other psychotic disorder
- Alcohol or other drug abuse (including abuse of prescription medications) within the past 6 months
- History of treatment non-adherence in other protocols run by the Mid-Life or Late-Life Centers
- Acute pain superimposed on chronic pain. For example, subjects who report "red flags" which suggest a herniated disk, vertebral fracture, infection, cauda equina syndrome, or other medical emergency will be excluded
- Wheelchair bound
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- History of documented non-response to duloxetine
- Concurrent use of thioridazine
- Active suicidal ideation with plan
- Uncontrolled narrow angle glaucoma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimizing Outcomes in Older Adults With Low Back Pain and Depression
The following primary hypotheses will be tested:
- During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in < 40% of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM) during the first 8 weeks will respond (response is defined as a Montgomery Asberg Depression Rating Scale (MADRS) score </=9 and at least a 30% improvement in back pain as measured with the 20-point numeric rating scale.
- During Step 2: More DUL+Problem Solving Therapy for Depression and Pain (PST-DP) than DUL+CM treated subjects will achieve response during the second 8 weeks, defined as a MADRS score </=9 and at least a 30% improvement in back pain as measured with the 2-point numeric rating scale.
- Improvement in depression scores will be correlated with improvement in CLBP scores.
Read more
The exploratory hypotheses to be tested are that:
During Step 2: Compared to subjects treated with DUL+CM, subjects treated with DUL+PST-DP will have improved outcomes in: 1) disability, 2) sleep, 2) functioning/quality of life, 3) caregiver burden/depression, and 5) analgesic use.
Read the detailed description
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
- Conditions
- Major Depressive Disorder, Back Pain, Aged
- Being tested
- Duloxetine
- Medical subject headings
- Depressive Disorder, Major, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Duloxetine = Cymbalta
Duloxetine up to 120 mg/day + Clinical Management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 PittsburghThe 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 4
- 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 Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eli Lilly and Company
- Responsible party
- Principal investigator, Jordan F. Karp, University of Pittsburgh
- Investigators
- Jordan F Karp, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696293
- Sponsor's protocol ID
- KL2RR024154
- Acronym
- ACHIEVE2
- Status last verified
- Jan 2017
- First submitted
- 9 Jun 2008
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19750557
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes in Older Adults With Low Back Pain and Depression
- ClinicalTrials.gov ID
- NCT00696293
- Acronym / sponsor ID
- ACHIEVE2 / KL2RR024154
- Conditions
- Major Depressive Disorder, Back Pain, Aged
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eli Lilly and Company
- Study start
- May 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The following primary hypotheses will be tested:
- During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in < 40% of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM) during the first 8 weeks will respond (response is defined as a Montgomery Asberg Depression Rating Scale (MADRS) score </=9 and at least a 30% improvement in back pain as measured with the 20-point numeric rating scale.
- During Step 2: More DUL+Problem Solving Therapy for Depression and Pain (PST-DP) than DUL+CM treated subjects will achieve response during the second 8 weeks, defined as a MADRS score </=9 and at least a 30% improvement in back pain as measured with the 2-point numeric rating scale.
- Improvement in depression scores will be correlated with improvement in CLBP scores.
The exploratory hypotheses to be tested are that:
During Step 2: Compared to subjects treated with DUL+CM, subjects treated with DUL+PST-DP will have improved outcomes in: 1) disability, 2) sleep, 2) functioning/quality of life, 3) caregiver burden/depression, and 5) analgesic use.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DuloxetineDuloxetine + 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >/= 60
- Current episode of MDD per SCID DSM-IV criteria
- Must score >/= 16 on the CES-D assessment
- Serum sodium >/=130 mEq/ml
- CLBP of at least moderate severity for more days than not for >/= 3 months
Key exclusion criteria (10 listed)
- Meet DSM-IV criteria for dementia
- History of bipolar, schizophrenia, schizoaffective, or other psychotic disorder
- Alcohol or other drug abuse (including abuse of prescription medications) within the past 6 months
- History of treatment non-adherence in other protocols run by the Mid-Life or Late-Life Centers
- Acute pain superimposed on chronic pain. For example, subjects who report "red flags" which suggest a herniated disk, vertebral fracture, infection, cauda equina syndrome, or other medical emergency will be excluded
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 |
|---|---|---|
| DuloxetineAlso: Duloxetine = CymbaltaDuloxetine up to 120 mg/day + Clinical Management | Drug | 1 |
Primary outcome
Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks
Time frame: 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
Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19750557Karp 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.
- Individual participant dataSharing planned: No
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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.
Jordan F Karp, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Major Depressive Disorder and Back Pain, run by University of Pittsburgh 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 12 inclusion and 10 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 1 Feb 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks (time frame: baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00696293, 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 1 Feb 2017.