Effect of Antidepressants on Back Pain

NCT00018200 | Completed Phase 2 DMC

• 1 other identifier: ADRD-018-98F
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.

Conditions

Back Pain; Sciatica

Keywords

analgesia; Back pain; sciatica

Outcome Measures

Primary Outcomes (1)

• Descriptor Differential Scale Pain Intensity

  12 weeks post baseline

Study Arms (3)

Arm 1

EXPERIMENTAL

Desipramine, low, middle or high exposure

Drug: Desipramine

Arm 2

EXPERIMENTAL

Fluoxetine, low, middle, or high exposure

Drug: Fluoxetine

Arm 3

PLACEBO COMPARATOR

Benztropine .125-.5mg daily

Drug: Benztropine

Interventions

Desipramine DRUG

Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)

Also known as: Anafranil

Arm 1

Fluoxetine DRUG

Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)

Also known as: Prozac

Arm 2

Benztropine DRUG

Daily dose 0.125 to 0.5mg

Also known as: Cogentin

Arm 3

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic back pain (pain on a daily basis for six months or longer)
• Age 18-65
• No major medical illness

You may not qualify if:

• medical contraindication to tricyclic antidepressants
• recent alcohol or substance use disorder
• bipolar disorder

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Publications (1)

• Atkinson JH, Slater MA, Capparelli EV, Wallace MS, Zisook S, Abramson I, Matthews SC, Garfin SR. Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial. J Clin Psychopharmacol. 2007 Apr;27(2):135-42. doi: 10.1097/jcp.0b013e3180333ed5.

  PMID: 17414235 RESULT

MeSH Terms

Conditions

Back Pain; Sciatica; Agnosia

Interventions

Desipramine; Clomipramine; Fluoxetine; Benztropine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Joseph H. Atkinson, MD

  VA San Diego Healthcare System, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2001
• First Posted: July 5, 2001
• Study Start: April 1, 1999
• Primary Completion: December 1, 2003
• Study Completion: March 1, 2004
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (1)