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

This study has been completed.
Sponsor:
Collaborators:
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: February 2, 2012
Last verified: February 2012
  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
Other: Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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:
  • Montgomery Asberg Depression Rating Scale and Numeric Rating Scale for Pain (20-item) [ Time Frame: 20 ] [ Designated as safety issue: No ]

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
1
Duloxetine + clinical management serves as the attention control for the active treatment, Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP)
Drug: Duloxetine
Duloxetine up to 120 mg/day + Clinical Management
Other Name: Duloxetine = Cymbalta
Active Comparator: 2
Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).
Other: Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).
Delivered over the course of 8-10 sessions.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
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
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: KL2 RR024154, KL2 RR024154
Study First Received: June 9, 2008
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Depression
Depressive Disorder
Low Back Pain
Depressive Disorder, Major
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014