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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00696293

Recruitment Status : Completed

First Posted : June 12, 2008

Results First Posted : May 26, 2016

Last Update Posted : February 1, 2017

Sponsor:

Collaborators:

National Institutes of Health (NIH)

Eli Lilly and Company

Information provided by (Responsible Party):

Jordan F. Karp, University of Pittsburgh

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder Back Pain Aged	Drug: Duloxetine	Phase 4

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Optimizing Outcomes in Older Adults With Low Back Pain and Depression
Study Start Date :	May 2007
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	April 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Depression

MedlinePlus related topics: Back Pain

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696293

Locations

Layout table for location information

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

Layout table for investigator information

Principal Investigator:	Jordan F Karp, MD	University of Pittsburgh

More Information

Publications of Results:

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.

Layout table for additonal information

Responsible Party:	Jordan F. Karp, Associate professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00696293
Other Study ID Numbers:	KL2RR024154 ( U.S. NIH Grant/Contract )
First Posted:	June 12, 2008 Key Record Dates
Results First Posted:	May 26, 2016
Last Update Posted:	February 1, 2017
Last Verified:	January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Back Pain Low Back Pain Depressive Disorder Depressive Disorder, Major Pain Neurologic Manifestations 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

To Top