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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eli Lilly and Company
Information provided by (Responsible Party):
Jordan F. Karp, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00696293
First received: June 9, 2008
Last updated: May 26, 2016
Last verified: May 2016
  Purpose

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 Rating Scale (MADRS) score </=9 and at least a 30% improvement in back pain as measured with the 20-point numeric rating scale.
  2. 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.
  3. 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.


Condition Intervention Phase
Major Depressive Disorder
Back Pain
Aged
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Outcomes in Older Adults With Low Back Pain and Depression

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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



Enrollment: 30
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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.

Drug: Duloxetine
Duloxetine up to 120 mg/day + Clinical Management
Other Name: Duloxetine = Cymbalta

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

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696293

Locations
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Eli Lilly and Company
Investigators
Principal Investigator: Jordan F Karp, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: Jordan F. Karp, Associate professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00696293     History of Changes
Other Study ID Numbers: KL2RR024154 
Study First Received: June 9, 2008
Results First Received: January 5, 2016
Last Updated: May 26, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Back Pain
Depressive Disorder
Low Back Pain
Depressive Disorder, Major
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents

ClinicalTrials.gov processed this record on August 23, 2016