Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 47 for:    DESIPRAMINE

Efficacy of Antidepressants in Chronic Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00964886
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Back Pain
Interventions Behavioral: cognitive behavioral therapy
Drug: desipramine hydrochloride
Drug: benztropine mesylate 0.125 mg daily
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description

desipramine hydrochloride

desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

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

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

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

Period Title: Overall Study
Started 38 34 37 33
Completed 27 27 21 24
Not Completed 11 7 16 9
Reason Not Completed
Lost to Follow-up             2             2             6             4
Withdrawal by Subject             6             2             5             3
Adverse Event             3             1             5             2
Protocol Violation             0             2             0             0
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Total
Hide Arm/Group Description

desipramine hydrochloride

desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 37 33 37 32 139
Hide Baseline Analysis Population Description
Demographic characteristics of participants randomized at baseline to one of the four study arms (selected information on three participants missing)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 33 participants 37 participants 32 participants 139 participants
56.5  (11.7) 57.8  (9.2) 51.5  (13.7) 57.9  (10.9) 55.8  (11.7)
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 33 participants 37 participants 31 participants 138 participants
Female
5
  13.5%
4
  12.1%
3
   8.1%
3
   9.7%
15
  10.9%
Male
32
  86.5%
29
  87.9%
34
  91.9%
28
  90.3%
123
  89.1%
[1]
Measure Analysis Population Description: Gender data missing on one participant.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 33 participants 37 participants 32 participants 139 participants
Hispanic or Latino
6
  16.2%
10
  30.3%
5
  13.5%
4
  12.5%
25
  18.0%
Not Hispanic or Latino
29
  78.4%
22
  66.7%
28
  75.7%
24
  75.0%
103
  74.1%
Unknown or Not Reported
2
   5.4%
1
   3.0%
4
  10.8%
4
  12.5%
11
   7.9%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 32 participants 37 participants 32 participants 138 participants
American Indian or Alaska Native
0
   0.0%
2
   6.3%
1
   2.7%
0
   0.0%
3
   2.2%
Asian
1
   2.7%
1
   3.1%
2
   5.4%
1
   3.1%
5
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   2.7%
1
   3.1%
2
   1.4%
Black or African American
6
  16.2%
6
  18.8%
4
  10.8%
5
  15.6%
21
  15.2%
White
25
  67.6%
18
  56.3%
21
  56.8%
20
  62.5%
84
  60.9%
More than one race
4
  10.8%
2
   6.3%
7
  18.9%
3
   9.4%
16
  11.6%
Unknown or Not Reported
1
   2.7%
3
   9.4%
1
   2.7%
2
   6.3%
7
   5.1%
[1]
Measure Analysis Population Description: Data missing on one participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 33 participants 37 participants 32 participants 139 participants
37 33 37 32 139
Pain Intensity and Back Pain Disability   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Pain Intensity (Descriptor Differential Scale) Number Analyzed 37 participants 33 participants 37 participants 32 participants 139 participants
9.9  (4.9) 11.9  (4.3) 11.9  (5.1) 12.1  (4.6) 11.4  (4.0)
Back Pain Disability (Roland and Morris) Number Analyzed 37 participants 33 participants 37 participants 32 participants 139 participants
8.7  (5.4) 13.0  (4.3) 11.7  (5.4) 12.6  (3.8) 11.8  (4.9)
[1]
Measure Description:

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

1.Primary Outcome
Title Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
Hide Description 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.
Time Frame 12 weeks after baseline (or last observation carried forward)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 + Arm 3 Arm 2 + Arm 4
Hide Arm/Group Description:

Factor desipramine hydrochloride

desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

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

Overall Number of Participants Analyzed 75 67
Mean (Standard Error)
Unit of Measure: units on a scale
8.3  (0.5) 8.1  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 + Arm 3, Arm 2 + Arm 4
Comments In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
Hide Description 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.
Time Frame 12 weeks after baseline (or last observation carried forward)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 2 + Arm 3 Arm 1 + Arm 4
Hide Arm/Group Description:

Factor 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

Factor no cognitive behavioral therapy
Overall Number of Participants Analyzed 71 71
Mean (Standard Error)
Unit of Measure: units on a scale
8.0  (0.6) 8.4  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 2 + Arm 3, Arm 1 + Arm 4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Roland and Morris Disability Questionnaire
Hide Description 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.
Time Frame 12 weeks after baseline (or last observation carried forward)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Arm 1 + Arm 3 Arm 2 + Arm 4
Hide Arm/Group Description:
Factor all participants assigned at baseline to receive desipramine hydrochloride
Factor all participants assigned at baseline to receive benztropine mesylate (active placebo)
Overall Number of Participants Analyzed 75 67
Mean (Standard Error)
Unit of Measure: Units on a scale.
8.7  (0.5) 8.9  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 + Arm 3, Arm 2 + Arm 4
Comments In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method ANCOVA
Comments Means are adjusted for baseline Roland and Morris scores.
4.Secondary Outcome
Title Roland and Morris Disability Questionnaire
Hide Description 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.
Time Frame 12 weeks after baseline (or last observation carried forward)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Arm 2 + Arm 3 Arm 1 + Arm 4
Hide Arm/Group Description:
Factor all participants assigned at baseline to receive cognitive behavioral therapy
Factor all participants assigned at baseline not to receive cognitive behavioral therapy
Overall Number of Participants Analyzed 71 71
Mean (Standard Error)
Unit of Measure: Units on a scale.
8.7  (0.5) 8.9  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 2 + Arm 3, Arm 1 + Arm 4
Comments This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Adverse Event Reporting Description Non-serious adverse advents were monitored for 70 participants.
 
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description

desipramine hydrochloride

desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

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

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

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

All-Cause Mortality
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/38 (2.63%)      0/34 (0.00%)      1/37 (2.70%)      0/33 (0.00%)    
Cardiac disorders         
fall * 1 [1]  0/38 (0.00%)  0 0/34 (0.00%)  0 1/37 (2.70%)  1 0/33 (0.00%)  0
Renal and urinary disorders         
urosepsis * 1 [2]  1/38 (2.63%)  1 0/34 (0.00%)  0 0/37 (0.00%)  0 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
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.
[2]
Hospitalized 2 days after starting study drug (desipramine) for urinary tract infection.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/17 (70.59%)      8/20 (40.00%)      7/16 (43.75%)      6/17 (35.29%)    
Endocrine disorders         
gynecomastia  1  0/17 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/17 (0.00%)  0
weight gain  1  0/17 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/17 (0.00%)  0
Eye disorders         
accomodation disturbance  1  2/17 (11.76%)  2 0/20 (0.00%)  0 2/16 (12.50%)  2 1/17 (5.88%)  1
Gastrointestinal disorders         
dry mouth  1  5/17 (29.41%)  5 3/20 (15.00%)  3 4/16 (25.00%)  4 1/17 (5.88%)  1
constipation  1  4/17 (23.53%)  4 1/20 (5.00%)  1 1/16 (6.25%)  1 1/17 (5.88%) 
General disorders         
diaphoresis  1  1/17 (5.88%)  1 1/20 (5.00%)  1 0/16 (0.00%)  0 0/17 (0.00%)  0
nausea  1  0/17 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
photosensitivity  1  1/17 (5.88%)  1 0/20 (0.00%)  0 0/16 (0.00%)  0 0/17 (0.00%)  0
Nervous system disorders         
decreased libido  1  1/17 (5.88%)  1 0/20 (0.00%)  0 0/16 (0.00%)  0 3/17 (17.65%)  3
increased dreaming  1  1/17 (5.88%)  1 2/20 (10.00%)  2 0/16 (0.00%)  0 1/17 (5.88%)  1
sedation  1  0/17 (0.00%)  0 1/20 (5.00%)  1 2/16 (12.50%)  2 0/17 (0.00%)  0
increased sleep duration  1  0/17 (0.00%)  0 2/20 (10.00%)  2 1/16 (6.25%)  1 0/17 (0.00%)  0
asthenia  1  0/17 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 1/17 (5.88%)  1
muscle rigidity  1  1/17 (5.88%)  1 1/20 (5.00%)  1 0/16 (0.00%)  0 0/17 (0.00%)  0
hyperkinesis  1  0/17 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 1/17 (5.88%)  1
dystonia  1  0/17 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/17 (0.00%)  0
dysarthria  1  0/17 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
ataxia  1  0/17 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
insomnia  1  1/17 (5.88%)  1 0/20 (0.00%)  0 0/16 (0.00%)  0 0/17 (0.00%)  0
paresthesia  1  0/17 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/17 (0.00%)  0
Psychiatric disorders         
depression  1  0/17 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders         
difficulty urinating  1  4/17 (23.53%)  4 1/20 (5.00%)  1 1/16 (6.25%)  1 1/17 (5.88%)  1
erectile dysfunction  1  3/17 (17.65%)  3 0/20 (0.00%)  0 0/16 (0.00%)  0 3/17 (17.65%)  3
ejaculatory dysfunction  1  2/17 (11.76%)  2 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
orgasm dysfunction  1  2/17 (11.76%)  2 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
polyuria  1  0/17 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph H. Atkinson MD
Organization: VA San Diego Healthcare System
Phone: 858 552 8585 ext 2568
EMail: joseph.atkinson@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00964886     History of Changes
Other Study ID Numbers: NURA-019-09S
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: November 23, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016