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

NCT00696293 | Completed Phase 4 Results

• 1 other identifier: KL2RR024154
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The following primary hypotheses will be tested:

1. 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. 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. 3.Improvement in depression scores will be correlated with improvement in CLBP scores.

Conditions

Major Depressive Disorder; Back Pain; Aged

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline and 12 weeks

Study Arms (1)

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.

Drug: Duloxetine

Interventions

Duloxetine DRUG

Duloxetine up to 120 mg/day + Clinical Management

Also known as: Duloxetine = Cymbalta

1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 19750557 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Back Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jordan F. Karp, MD
• Organization: University of Pittsburgh

karpjf@upmc.edu

412-246-6048

Study Officials

• Jordan F Karp, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: May 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 1, 2017
• Results First Posted: May 26, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)