Effect of Antidepressants on Back Pain

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Desipramine

Drug

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

Other names: Anafranil

Fluoxetine

Drug

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

Other names: Prozac

Benztropine

Drug

Daily dose 0.125 to 0.5mg

Other names: Cogentin

Primary outcomes

Descriptor Differential Scale Pain Intensity

Time frame: 12 weeks post baseline

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Efficacy of Antidepressants in Chronic Back Pain

Important dates

Study start: 1999
Primary completion: 2003
Study completion: 2004
First posted: Jul 5, 2001
Registry last updated: Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed