Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2010-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
desipramine hydrochloride
desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Arm 2
cognitive behavioral therapy
cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Arm 3
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Arm 4
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
Interventions
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cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
benztropine mesylate 0.125 mg daily
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Joseph H Atkinson, MD
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Locations
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VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Countries
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References
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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.
Other Identifiers
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NURA-019-09S
Identifier Type: -
Identifier Source: org_study_id