Trial · NCT00964886
Efficacy of Antidepressants in Chronic Back Pain
NCT00964886, Phase 2, Completed, VA Office of Research and Development; results first posted 2016-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Antidepressants in Chronic Back Pain. Trials, record NCT00964886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00964886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Antidepressants in Chronic Back Pain
- NCT number
- NCT00964886
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Back Pain
- Interventions
- cognitive behavioral therapy, desipramine hydrochloride, cognitive behavioral therapy, benztropine mesylate 0.125 mg daily, desipramine hydrochloride
- First posted
- 2009-08-25
- Last updated
- 2016-11-29
- Results first posted
- 2016-11-29
- 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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | 12 weeks after baseline (or last observation carried forward) | 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. |
| Secondary | Roland and Morris Disability Questionnaire | 12 weeks after baseline (or last observation carried forward) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | 12 weeks after baseline (or last observation carried forward) | 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. | units on a scale | MEAN |
| SECONDARY | Roland and Morris Disability Questionnaire | 12 weeks after baseline (or last observation carried forward) | 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 | Units on a scale. | MEAN |
| PRIMARY | Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | 12 weeks after baseline (or last observation carried forward) | 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. | units on a scale | MEAN |
| SECONDARY | Roland and Morris Disability Questionnaire | 12 weeks after baseline (or last observation carried forward) | 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 | Units on a scale. | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | Arm 1 + Arm 3 | 8.3 | Standard Error 0.5 | units on a scale | |
| Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | Arm 2 + Arm 4 | 8.1 | Standard Error 0.6 | units on a scale | |
| Roland and Morris Disability Questionnaire | Arm 1 + Arm 3 | 8.7 | Standard Error 0.5 | Units on a scale. | |
| Roland and Morris Disability Questionnaire | Arm 2 + Arm 4 | 8.9 | Standard Error 0.5 | Units on a scale. | |
| Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | Arm 2 + Arm 3 | 8.0 | Standard Error 0.6 | units on a scale | |
| Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity | Arm 1 + Arm 4 | 8.4 | Standard Error 0.6 | units on a scale | |
| Roland and Morris Disability Questionnaire | Arm 2 + Arm 3 | 8.7 | Standard Error 0.5 | Units on a scale. | |
| Roland and Morris Disability Questionnaire | Arm 1 + Arm 4 | 8.9 | Standard Error 0.5 | Units on a scale. |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 38 | |
| Overall Study | STARTED | Arm 2 | 34 | |
| Overall Study | STARTED | Arm 3 | 37 | |
| Overall Study | STARTED | Arm 4 | 33 | |
| Overall Study | COMPLETED | Arm 1 | 27 | |
| Overall Study | COMPLETED | Arm 2 | 27 | |
| Overall Study | COMPLETED | Arm 3 | 21 | |
| Overall Study | COMPLETED | Arm 4 | 24 | |
| Overall Study | NOT COMPLETED | Arm 1 | 11 | |
| Overall Study | NOT COMPLETED | Arm 2 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | dry mouth | Gastrointestinal disorders | Arm 1 | 5 | 17 | 5 |
| other | dry mouth | Gastrointestinal disorders | Arm 2 | 3 | 20 | 3 |
| other | dry mouth | Gastrointestinal disorders | Arm 3 | 4 | 16 | 4 |
| other | dry mouth | Gastrointestinal disorders | Arm 4 | 1 | 17 | 1 |
| other | difficulty urinating | Renal and urinary disorders | Arm 1 | 4 | 17 | 4 |
| other | difficulty urinating | Renal and urinary disorders | Arm 2 | 1 | 20 | 1 |
| other | difficulty urinating | Renal and urinary disorders | Arm 3 | 1 | 16 | 1 |
| other | difficulty urinating | Renal and urinary disorders | Arm 4 | 1 | 17 | 1 |
| other | constipation | Gastrointestinal disorders | Arm 1 | 4 | 17 | 4 |
| other | constipation | Gastrointestinal disorders | Arm 2 | 1 | 20 | 1 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, all-cause mortality | Arm 3 | ||
| Total, all-cause mortality | Arm 4 | ||
| Total, other adverse events | Arm 1 | 12 | 17 |
| Total, other adverse events | Arm 2 | 8 | 20 |
| Total, other adverse events | Arm 3 | 7 | 16 |
| Total, other adverse events | Arm 4 | 6 | 17 |
| Total, serious adverse events | Arm 1 | 1 | 38 |
| Total, serious adverse events | Arm 2 | 0 | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32068667 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00964886
GET https://conductscience.org/api/trials/v1/NCT00964886/events?page=2