Comparative effect of collaborative care, pain medication, and duloxetine in the treatment of major depressive disorder and comorbid (sub)chronic pain

Results of an exploratory randomized, placebo-controlled, multicenter trial (cc: paindip)

E.W. de Heer, J. Dekker, A.T.F. Beekman, H.W.J. van Marwijk, T.J. Holwerda, P.M. Bet, J. Roth, L. Timmerman, C.M. van der Feltz-Cornelis

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Abstract

Objective:
Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature.

Methods:
Three-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089).

Results:
Sixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = -0.78; p = 0.01). Non-compliant patients (n = 31) did not improve over the 12-week period, in contrast to compliant patients (n = 29). Pain outcomes did not differ between the three groups.

Conclusion:
In MDD and pain, patient's compliance and placebo effects are more important in attaining effect than choice of one of the treatments. Active pain management with COX inhibitors and pregabalin as alternatives to tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The generalizability is limited due to the small sample size. Larger studies are needed.
Original languageEnglish
Article number118
Number of pages13
JournalFrontiers in Psychology
Volume9
DOIs
Publication statusPublished - 2018

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Chronic Pain
Multicenter Studies
Placebos
Major Depressive Disorder
Depression
Mental Health
Duloxetine Hydrochloride
Pain Management
Acetaminophen
Ambulatory Care Facilities
Netherlands
Delivery of Health Care

Keywords

  • ANALGESIC LADDER
  • ANXIETY DISORDERS
  • COST-UTILITY ANALYSIS
  • DOUBLE-BLIND
  • JAPANESE PATIENTS
  • LOW-BACK-PAIN
  • METAANALYSIS
  • PHYSICAL SYMPTOMS
  • RISK
  • STEPPED CARE
  • algorithm
  • collaborative care
  • depression
  • duloxetine
  • pain
  • placebo
  • pregabalin

Cite this

@article{bd22f5e7ab7b40f88c66bf8a98da028f,
title = "Comparative effect of collaborative care, pain medication, and duloxetine in the treatment of major depressive disorder and comorbid (sub)chronic pain: Results of an exploratory randomized, placebo-controlled, multicenter trial (cc: paindip)",
abstract = "Objective:Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature.Methods:Three-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089).Results:Sixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = -0.78; p = 0.01). Non-compliant patients (n = 31) did not improve over the 12-week period, in contrast to compliant patients (n = 29). Pain outcomes did not differ between the three groups.Conclusion:In MDD and pain, patient's compliance and placebo effects are more important in attaining effect than choice of one of the treatments. Active pain management with COX inhibitors and pregabalin as alternatives to tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The generalizability is limited due to the small sample size. Larger studies are needed.",
keywords = "ANALGESIC LADDER, ANXIETY DISORDERS, COST-UTILITY ANALYSIS, DOUBLE-BLIND, JAPANESE PATIENTS, LOW-BACK-PAIN, METAANALYSIS, PHYSICAL SYMPTOMS, RISK, STEPPED CARE, algorithm, collaborative care, depression, duloxetine, pain, placebo, pregabalin",
author = "{de Heer}, E.W. and J. Dekker and A.T.F. Beekman and {van Marwijk}, H.W.J. and T.J. Holwerda and P.M. Bet and J. Roth and L. Timmerman and {van der Feltz-Cornelis}, C.M.",
year = "2018",
doi = "10.3389/fpsyt.2018.00118",
language = "English",
volume = "9",
journal = "Frontiers in Psychology",
issn = "1664-1078",
publisher = "Frontiers Media S.A.",

}

Comparative effect of collaborative care, pain medication, and duloxetine in the treatment of major depressive disorder and comorbid (sub)chronic pain : Results of an exploratory randomized, placebo-controlled, multicenter trial (cc: paindip). / de Heer, E.W.; Dekker, J.; Beekman, A.T.F.; van Marwijk, H.W.J.; Holwerda, T.J.; Bet, P.M.; Roth, J.; Timmerman, L.; van der Feltz-Cornelis, C.M.

In: Frontiers in Psychology, Vol. 9, 118, 2018.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - Comparative effect of collaborative care, pain medication, and duloxetine in the treatment of major depressive disorder and comorbid (sub)chronic pain

T2 - Results of an exploratory randomized, placebo-controlled, multicenter trial (cc: paindip)

AU - de Heer, E.W.

AU - Dekker, J.

AU - Beekman, A.T.F.

AU - van Marwijk, H.W.J.

AU - Holwerda, T.J.

AU - Bet, P.M.

AU - Roth, J.

AU - Timmerman, L.

AU - van der Feltz-Cornelis, C.M.

PY - 2018

Y1 - 2018

N2 - Objective:Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature.Methods:Three-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089).Results:Sixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = -0.78; p = 0.01). Non-compliant patients (n = 31) did not improve over the 12-week period, in contrast to compliant patients (n = 29). Pain outcomes did not differ between the three groups.Conclusion:In MDD and pain, patient's compliance and placebo effects are more important in attaining effect than choice of one of the treatments. Active pain management with COX inhibitors and pregabalin as alternatives to tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The generalizability is limited due to the small sample size. Larger studies are needed.

AB - Objective:Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature.Methods:Three-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089).Results:Sixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = -0.78; p = 0.01). Non-compliant patients (n = 31) did not improve over the 12-week period, in contrast to compliant patients (n = 29). Pain outcomes did not differ between the three groups.Conclusion:In MDD and pain, patient's compliance and placebo effects are more important in attaining effect than choice of one of the treatments. Active pain management with COX inhibitors and pregabalin as alternatives to tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The generalizability is limited due to the small sample size. Larger studies are needed.

KW - ANALGESIC LADDER

KW - ANXIETY DISORDERS

KW - COST-UTILITY ANALYSIS

KW - DOUBLE-BLIND

KW - JAPANESE PATIENTS

KW - LOW-BACK-PAIN

KW - METAANALYSIS

KW - PHYSICAL SYMPTOMS

KW - RISK

KW - STEPPED CARE

KW - algorithm

KW - collaborative care

KW - depression

KW - duloxetine

KW - pain

KW - placebo

KW - pregabalin

U2 - 10.3389/fpsyt.2018.00118

DO - 10.3389/fpsyt.2018.00118

M3 - Article

VL - 9

JO - Frontiers in Psychology

JF - Frontiers in Psychology

SN - 1664-1078

M1 - 118

ER -