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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | desipramine hydrochloride |
|
| Arm 2 | Experimental | cognitive behavioral therapy |
|
| Arm 3 | Experimental | desipramine hydrochloride and cognitive behavioral therapy |
|
| Arm 4 | Placebo Comparator | anticholinergic medication; active placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive behavioral therapy | Behavioral | cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Roland and Morris Disability Questionnaire | This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph H Atkinson, MD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32068667 | Derived | 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. |
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Available in SPSS format from the investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | desipramine hydrochloride desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic characteristics of participants randomized at baseline to one of the four study arms (selected information on three participants missing)
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | desipramine hydrochloride desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We conducted an intent-to-treat analysis of all randomized participants assigned to desipramine or to active drug placebo (benztropine) comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score. | Posted | Mean | Standard Error | units on a scale | 12 weeks after baseline (or last observation carried forward) |
|
Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | desipramine hydrochloride desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urosepsis | Renal and urinary disorders | SNOMED CT | Non-systematic Assessment | Hospitalized 2 days after starting study drug (desipramine) for urinary tract infection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dry mouth | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph H. Atkinson MD | VA San Diego Healthcare System | 858 552 8585 | 2568 | joseph.atkinson@va.gov |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D003891 | Desipramine |
| D002997 | Clomipramine |
| D001590 | Benztropine |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003984 | Dibenzazepines |
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| desipramine hydrochloride | Drug | desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml |
|
|
| cognitive behavioral therapy | Behavioral | 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 | Drug | benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride |
|
|
| desipramine hydrochloride | Drug | desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml |
|
|
| 12 weeks after baseline (or last observation carried forward) |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Protocol Violation |
|
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Gender data missing on one participant. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data missing on one participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain Intensity and Back Pain Disability | The DDS is self-report measure of "current" pain intensity on a 20 point scale 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 Roland and Morris questionnaire is a 24-item checklist asking patients whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain | Mean | Standard Deviation | units on a scale |
|
Factor desipramine hydrochloride desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml |
| OG001 | Arm 2 + Arm 4 | Factor 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 |
|
|
|
| Secondary | Roland and Morris Disability Questionnaire | This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values. | All participants assigned at baseline to receive desipramine hydrochloride or benztropine mesylate (drug effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores | Posted | Mean | Standard Error | Units on a scale. | 12 weeks after baseline (or last observation carried forward) |
|
|
|
|
| Primary | 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. | We conducted an intent-to-treat analysis of all randomized participants assigned to cognitive behavioral therapy to or no behavior therapy comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score. | Posted | Mean | Standard Error | units on a scale | 12 weeks after baseline (or last observation carried forward) |
|
|
|
|
| Secondary | Roland and Morris Disability Questionnaire | This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values. | All participants assigned at baseline to receive cognitive behavioral therapy or to no cognitive behavioral therapy (behavioral effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores | Posted | Mean | Standard Error | Units on a scale. | 12 weeks after baseline (or last observation carried forward) |
|
|
|
|
| 1 |
| 38 |
| 12 |
| 17 |
| EG001 | 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 | 0 | 34 | 8 | 20 |
| EG002 | 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 | 1 | 37 | 7 | 16 |
| EG003 | 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 | 0 | 33 | 6 | 17 |
|
| fall | Cardiac disorders | SNOMED CT | Non-systematic Assessment | Fell off bed while attempting to swat an insect on ceiling.Reported to emergency department for treatment of laceration of scalp. After suturing he converted from regular sinus rhythm to atrial fibrillation. Was admitted for cardioversion. |
|
| difficulty urinating | Renal and urinary disorders | SNOMED CT | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
| erectile dysfunction | Renal and urinary disorders | SNOMED CT | Systematic Assessment |
|
| accomodation disturbance | Eye disorders | SNOMED CT | Systematic Assessment |
|
| decreased libido | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| increased dreaming | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| sedation | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| increased sleep duration | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| ejaculatory dysfunction | Renal and urinary disorders | SNOMED CT | Systematic Assessment |
|
| orgasm dysfunction | Renal and urinary disorders | SNOMED CT | Systematic Assessment |
|
| asthenia | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| diaphoresis | General disorders | SNOMED CT | Systematic Assessment |
|
| muscle rigidity | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| hyperkinesis | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| depression | Psychiatric disorders | SNOMED CT | Systematic Assessment |
|
| dystonia | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| dysarthria | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| ataxia | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| gynecomastia | Endocrine disorders | SNOMED CT | Systematic Assessment |
|
| insomnia | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| nausea | General disorders | SNOMED CT | Systematic Assessment |
|
| photosensitivity | General disorders | SNOMED CT | Systematic Assessment |
|
| paresthesia | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| polyuria | Renal and urinary disorders | SNOMED CT | Systematic Assessment |
|
| weight gain | Endocrine disorders | SNOMED CT | Systematic Assessment |
|
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| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|