Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults (ACHIEVE2)
This study has been completed.
Sponsor:
University of Pittsburgh
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
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Purpose
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 | 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
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 Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013