ADAPT: Addressing Depression and Pain Together

NCT01124188 | Completed Phase 4 Results DMC

• 1 other identifier: AG033575
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or non-response?

Conditions

Depression; Back Pain

Keywords

Geriatric psychiatry; Aged; Elderly; Venlafaxine; Self efficacy; Pain; Psychotherapy; Effexor

Outcome Measures

Primary Outcomes (1)

• Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization

  The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry.

  14 weeks

Secondary Outcomes (2)

• Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks

  Baseline and 14 weeks

• Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks

  Baseline and 14 weeks

Study Arms (2)

Study Intervention Arm

EXPERIMENTAL

Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)

Drug: Higher-dose venlafaxine; Behavioral: Problem Solving Therapy for Depression and Pain

Active Control

ACTIVE COMPARATOR

Higher-dose venlafaxine and supportive management (SM)

Drug: Higher-dose venlafaxine; Behavioral: Supportive management

Interventions

Higher-dose venlafaxine DRUG

Dosing of venlafaxine will range from 187.5-300 mg/day.

Also known as: Effexor

Active Control; Study Intervention Arm

Supportive management BEHAVIORAL

Supportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.

Active Control

Problem Solving Therapy for Depression and Pain BEHAVIORAL

PST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component.

Also known as: PST-DP

Study Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Age 60 or older
• Scores 10 or higher on the Patient Health Questionnaire-9 (PHQ-9). This is consistent with at least moderate depression severity.
• Endorses low back pain more days than not, of at least moderate severity, for at least the past 3 months.
• If venlafaxine up to 150 mg/day has been tried for at least 6 weeks, subjects must have been \*completely\* unresponsive for both depression and low back pain (based on subject report).
• During this episode of CLBP, must have tried without continued success any of the following: 1) prescription or over the counter analgesics, 2) physical therapy, 3) acupuncture, 4) injection therapy, 5) had back surgery, 6) multidisciplinary pain program, 7) psychological treatment for chronic pain such as cognitive behavioral therapy or biofeedback, or 8) any other physician-prescribed treatment for chronic low back pain.
• Repeat PHQ-9 with score
• Current depression (major depression, partial remission of major depression, minor depression, or dysthymia) diagnosed with the PRIMEMD
• item Numeric Rating Scale for low back pain
• The Montreal Cognitive Assessment (MoCA). Eligibility requires score of at least 24
• No history of alcohol/substance abuse or dependence for the past six months. If subjects took more analgesics than prescribed for CLBP but there was no other evidence of abuse, they will be included. Alcohol and substance abuse will be assessed with the MINI-International Neuropsychiatric Interview.

You may not qualify if:

• Wheelchair-bound as this level of disability does not represent most older adults living with CLBP.
• Diagnosed with fibromyalgia; there is evidence that individuals with fibromyalgia may have a differential treatment response to SNRIs.
• Involved in a lawsuit related to back pain and/or receiving workers compensation.
• Current or past psychotic-spectrum disorder or current or past bipolar disorder. This will be determined with the PRIME-MD and MINI-Neuropsychiatric interview.
• Medically unstable, delirious, or terminally ill; or medical contraindication to use of venlafaxine therapy, including hypersensitivity, history of venlafaxine-induced SIADH, uncontrolled narrow angle glaucoma, AST or ALT \> 1.5x upper limit of normal.
• Acute low back pain "red flag" superimposed on chronic low back pain suggesting medically emergent condition (e.g., vertebral fracture, infection, cauda equina syndrome, disk herniation, cancer).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Late Life Depression Program

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (9)

• 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 BACKGROUND

• Karp JF, Skidmore E, Lotz M, Lenze E, Dew MA, Reynolds CF 3rd. Use of the late-life function and disability instrument to assess disability in major depression. J Am Geriatr Soc. 2009 Sep;57(9):1612-9. doi: 10.1111/j.1532-5415.2009.02398.x. Epub 2009 Jul 21.

  PMID: 19682111 BACKGROUND

• Karp JF, Reynolds CF 3rd, Butters MA, Dew MA, Mazumdar S, Begley AE, Lenze E, Weiner DK. The relationship between pain and mental flexibility in older adult pain clinic patients. Pain Med. 2006 Sep-Oct;7(5):444-52. doi: 10.1111/j.1526-4637.2006.00212.x.

  PMID: 17014605 BACKGROUND

• Karp JF, Weiner D, Seligman K, Butters M, Miller M, Frank E, Stack J, Mulsant BH, Pollock B, Dew MA, Kupfer DJ, Reynolds CF 3rd. Body pain and treatment response in late-life depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):188-94. doi: 10.1176/appi.ajgp.13.3.188.

  PMID: 15728749 BACKGROUND

• Arean P, Hegel M, Vannoy S, Fan MY, Unuzter J. Effectiveness of problem-solving therapy for older, primary care patients with depression: results from the IMPACT project. Gerontologist. 2008 Jun;48(3):311-23. doi: 10.1093/geront/48.3.311.

  PMID: 18591356 BACKGROUND

• Karp JF, Shega JW, Morone NE, Weiner DK. Advances in understanding the mechanisms and management of persistent pain in older adults. Br J Anaesth. 2008 Jul;101(1):111-20. doi: 10.1093/bja/aen090. Epub 2008 May 16.

  PMID: 18487247 BACKGROUND

• Stahl ST, Jung C, Weiner DK, Pecina M, Karp JF. Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression. Pain Med. 2020 Aug 1;21(8):1538-1545. doi: 10.1093/pm/pnz279.

  PMID: 31633789 DERIVED

• Wei W, Karim HT, Lin C, Mizuno A, Andreescu C, Karp JF, Reynolds CF 3rd, Aizenstein HJ. Trajectories in Cerebral Blood Flow Following Antidepressant Treatment in Late-Life Depression: Support for the Vascular Depression Hypothesis. J Clin Psychiatry. 2018 Oct 23;79(6):18m12106. doi: 10.4088/JCP.18m12106.

  PMID: 30358242 DERIVED

• Rej S, Dew MA, Karp JF. Treating concurrent chronic low back pain and depression with low-dose venlafaxine: an initial identification of "easy-to-use" clinical predictors of early response. Pain Med. 2014 Jul;15(7):1154-62. doi: 10.1111/pme.12456. Epub 2014 Jul 4.

  PMID: 25040462 DERIVED

Related Links

• The Late-Life Depression Evaluation and Treatment Center provides information and treatment for depression, anxiety disorders, and insomnia in older Americans.
• The University of Pittsburgh Institute on Aging provides access to a multidisciplinary network of comprehensive clinical care.
• The American Association for Geriatric Psychiatry is a national association representing and serving its members and the field of geriatric psychiatry.
• website describing the study

MeSH Terms

Conditions

Depression; Back Pain; Pain

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Results Point of Contact

• Title: Jordan F. Karp, MD
• Organization: UPMC Late Life Depression

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Anesthesiology, and Clinical and Translational Science

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)