Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Institutes of Health (NIH) Eli Lilly and Company
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00696293

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 IV

MedlinePlus related topics: Back Pain Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

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 ]

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
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
2: Active Comparator 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

Contacts

Contact: Jackie Stack

412-246-6006

stackja@upmc.edu

Locations

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

Sponsors and Collaborators

University of Pittsburgh

National Institutes of Health (NIH)

Eli Lilly and Company

Investigators

Principal Investigator:

Jordan F Karp, MD

University of Pittsburgh

More Information

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
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Depression
Low Back Pain
Pain
Depressive Disorder, Major
Depressive Disorder
Back Pain
Duloxetine

Serotonin
Behavioral Symptoms
Signs and Symptoms
Dopamine
Mental Disorders
Mood Disorders
Neurologic Manifestations

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs

Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009