Efficacy of Antidepressants in Chronic Back Pain

NCT00964886 | Completed Phase 2 Results DMC

• 1 other identifier: NURA-019-09S
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

Conditions

Back Pain

Keywords

chronic pain; back pain; antidepressants

Outcome Measures

Primary Outcomes (1)

• Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity

  The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.

  12 weeks after baseline (or last observation carried forward)

Secondary Outcomes (1)

• Roland and Morris Disability Questionnaire

  12 weeks after baseline (or last observation carried forward)

Study Arms (4)

Arm 1

EXPERIMENTAL

desipramine hydrochloride

Drug: desipramine hydrochloride

Arm 2

EXPERIMENTAL

cognitive behavioral therapy

Behavioral: cognitive behavioral therapy

Arm 3

EXPERIMENTAL

desipramine hydrochloride and cognitive behavioral therapy

Drug: desipramine hydrochloride; Behavioral: cognitive behavioral therapy

Arm 4

PLACEBO COMPARATOR

anticholinergic medication; active placebo

Drug: benztropine mesylate 0.125 mg daily

Interventions

cognitive behavioral therapy BEHAVIORAL

cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life

Arm 2

desipramine hydrochloride DRUG

desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

Also known as: Anafranil

Arm 3

benztropine mesylate 0.125 mg daily DRUG

benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride

Also known as: Cogentin

Arm 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic back pain (daily pain for \> 6 months)

You may not qualify if:

• Major medical conditions which might contraindicate antidepressant treatment

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Diego: collaborator

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (1)

• Gould HM, Atkinson JH, Chircop-Rollick T, D'Andrea J, Garfin S, Patel SM, Funk SD, Capparelli EV, Penzien DB, Wallace M, Weickgenanta AL, Slater M, Rutledge T. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain. 2020 Jun;161(6):1341-1349. doi: 10.1097/j.pain.0000000000001834.

  PMID: 32068667 DERIVED

MeSH Terms

Conditions

Back Pain; Chronic Pain

Interventions

Cognitive Behavioral Therapy; Desipramine; Clomipramine; Benztropine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

Failure to attain recruitment goals and attrition resulted in lack of power to detect an effect. A strong active placebo control condition (benztropine) and frequent follow up visits may have led to improvement in all groups over time.

Results Point of Contact

• Title: Joseph H. Atkinson MD
• Organization: VA San Diego Healthcare System

joseph.atkinson@va.gov

858 552 8585

Study Officials

• Joseph H Atkinson, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 29, 2016
• Results First Posted: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)