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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00696293
• Date of registration: 09/06/2008
• Primary sponsor: University of Pittsburgh
• Public title: Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults ACHIEVE2
• Scientific title: Optimizing Outcomes in Older Adults With Low Back Pain and Depression
• Date of first enrolment: May 2007
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00696293
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jordan F Karp, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aged

Back Pain

Major Depressive Disorder

Intervention(s)

Drug: Duloxetine

Other: Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).

Primary Outcome(s)

Montgomery Asberg Depression Rating Scale and Numeric Rating Scale for Pain (20-item) [Time Frame: 20]

Secondary ID(s)

KL2 RR024154

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

National Institutes of Health (NIH)