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Sponsors and Collaborators: |
University of Pittsburgh National Institutes of Health (NIH) Eli Lilly and Company |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00696293 |
The following primary hypotheses will be tested:
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 |
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Major Depressive Disorder Back Pain Aged |
Drug: Duloxetine Other: Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP). |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Optimizing Outcomes in Older Adults With Low Back Pain and Depression |
Estimated Enrollment: | 80 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Duloxetine + clinical management serves as the attention control for the active treatment, Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP)
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Drug: Duloxetine
Duloxetine up to 120 mg/day + Clinical Management
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2: Active Comparator
Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).
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Other: Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).
Delivered over the course of 8-10 sessions.
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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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
Contact: Jackie Stack | 412-246-6006 | stackja@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh School of Medicine | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Jackie Stack, MSN 412-246-6006 stackja@upmc.edu | |
Principal Investigator: Jordan F Karp, MD |
Principal Investigator: | Jordan F Karp, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh School of Medicine ( Jordan F. Karp MD, Assistant Professor of Psychiatry and Anesthesiology ) |
Study ID Numbers: | KL2 RR024154, KL2 RR024154 |
Study First Received: | June 9, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00696293 History of Changes |
Health Authority: | United States: Institutional Review Board |
Dopamine Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Psychotropic Drugs Low Back Pain Pain Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Back Pain |
Duloxetine Serotonin Behavioral Symptoms Signs and Symptoms Dopamine Mental Disorders Mood Disorders Neurologic Manifestations Dopamine Agents Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Pain Depressive Disorder, Major Duloxetine Signs and Symptoms Mental Disorders Therapeutic Uses |
Antidepressive Agents Depression Nervous System Diseases Low Back Pain Depressive Disorder Back Pain Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Serotonin Agents Mood Disorders Neurologic Manifestations Dopamine Agents Central Nervous System Agents |