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Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults (ACHIEVE2)

Primary Purpose

Major Depressive Disorder, Back Pain, Aged

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • History of documented non-response to duloxetine
  • Concurrent use of thioridazine
  • Active suicidal ideation with plan
  • Uncontrolled narrow angle glaucoma

Sites / Locations

  • University of Pittsburgh School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2008
Last Updated
January 30, 2017
Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00696293
Brief Title
Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
Acronym
ACHIEVE2
Official Title
Optimizing Outcomes in Older Adults With Low Back Pain and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Back Pain, Aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Duloxetine = Cymbalta
Intervention Description
Duloxetine up to 120 mg/day + Clinical Management
Primary Outcome Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks
Description
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
Time Frame
baseline and 12 weeks
Title
Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks
Description
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
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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 History of documented non-response to duloxetine Concurrent use of thioridazine Active suicidal ideation with plan Uncontrolled narrow angle glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan F Karp, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19750557
Citation
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.
Results Reference
result

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Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults

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