Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

May 2, 2014 updated by: Boehringer Ingelheim

A 12 Weeks Open Label Two Parallel Groups Study to Assess the Efficacy of Orally Administered Duloxetine 60 mg and 120 mg Per Day on Treatment Outcomes in Patients With Diabetic Peripheral Neuropathic Pain With and Without Co-morbid Major Depressive Disorder. The Primary Objective of This Study is to Evaluate Whether the Efficacy of Duloxetine Given as 60 mg to 120 mg Once Daily (QD), Measured by the BPI Interference Score After 12 Weeks Shows a Clinically Relevant Improvement in the DPNP Patients With Co-morbid MDD

The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis.

As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain.

The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI).

As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale.

Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated.

To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.

Study Overview

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Achim bei Bremen, Germany
        • 1208.34.49008 Boehringer Ingelheim Investigational Site
      • Aschaffenburg, Germany
        • 1208.34.49025 Boehringer Ingelheim Investigational Site
      • Bad Mergentheim, Germany
        • 1208.34.49001 Boehringer Ingelheim Investigational Site
      • Baesweiler, Germany
        • 1208.34.49018 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1208.34.49002 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1208.34.49005 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1208.34.49009 Boehringer Ingelheim Investigational Site
      • Berlin-Steglitz, Germany
        • 1208.34.49007 Boehringer Ingelheim Investigational Site
      • Bremen, Germany
        • 1208.34.49021 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Germany
        • 1208.34.49028 Boehringer Ingelheim Investigational Site
      • Gera, Germany
        • 1208.34.49012 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1208.34.49004 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1208.34.49020 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1208.34.49023 Boehringer Ingelheim Investigational Site
      • Hattingen, Germany
        • 1208.34.49015 Boehringer Ingelheim Investigational Site
      • Heidenheim, Germany
        • 1208.34.49027 Boehringer Ingelheim Investigational Site
      • Kelkheim, Germany
        • 1208.34.49016 Boehringer Ingelheim Investigational Site
      • Limburgerhof, Germany
        • 1208.34.49006 Boehringer Ingelheim Investigational Site
      • Münster, Germany
        • 1208.34.49022 Boehringer Ingelheim Investigational Site
      • Neuwied, Germany
        • 1208.34.49019 Boehringer Ingelheim Investigational Site
      • St. Ingberg, Germany
        • 1208.34.49024 Boehringer Ingelheim Investigational Site
      • Stuhr, Germany
        • 1208.34.49010 Boehringer Ingelheim Investigational Site
      • Unterhaching, Germany
        • 1208.34.49013 Boehringer Ingelheim Investigational Site
      • Wiesbaden, Germany
        • 1208.34.49029 Boehringer Ingelheim Investigational Site
      • Wuppertal, Germany
        • 1208.34.49026 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
  2. To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
  3. Male or female outpatients at least 18 years of age.
  4. Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
  5. Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
  6. Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Exclusion criteria:

  1. Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
  2. Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
  3. Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
  4. Have previously been treated with duloxetine (for DPNP or MDD)
  5. Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II).
  6. Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DPNP with depression (1)
Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
Other: DPNP with depression (2)
Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated
Other: DPNP without depression (1)
Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
Other: DPNP without depression (2)
Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)
given to (1) all patients week 2-6; (2) all responders of both arms week 7-12
given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)
given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down
given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)
given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD
given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in BPI Worst Pain During Treatment From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 2
Change in Worst Pain (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 6
Change in Worst Pain (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 12
Change in Least Pain (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 2
Change in Least Pain During Treatment (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 6
Change in Least Pain (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 12
Change in Average Pain (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 2
Change in Average Pain During Treatment (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 6
Change in Average Pain (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 12
Number of Patients With a Reduction in BPI Average Pain at Week 2
Time Frame: Baseline and Week 2
Baseline and Week 2
Number of Patients With a Reduction in BPI Average Pain at Week 6
Time Frame: Baseline and Week 6
Baseline and Week 6
Number of Patients With a Reduction in BPI Average Pain at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change in Pain During Treatment (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 2
Change in Pain (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 6
Change in Pain During Treatment (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).
Baseline and Week 12
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).
Baseline and Week 2
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).
Baseline and Week 6
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).
Baseline and Week 12
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Change in Interference of Pain With Mood (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With Mood (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With Mood (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 2
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 6
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).
Baseline and Week 12
Patient Global Impression - Improvement (PGI-I) at Week 2
Time Frame: Baseline and Week 2
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Baseline and Week 2
Patient Global Impression - Improvement (PGI-I) at Week 6
Time Frame: Baseline and Week 6
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Baseline and Week 6
Patient Global Impression - Improvement (PGI-I) at Week 12
Time Frame: Baseline and Week 12
The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Baseline and Week 12
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.
Baseline and Week 2
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.
Baseline and Week 6
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.
Baseline and Week 12
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).
Baseline and Week 2
Change in HADS Anxiety Total Score From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).
Baseline and Week 6
Change in HADS Anxiety Total Score From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).
Baseline and Week 12
Change in HADS Depression Total Score From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).
Baseline and Week 2
Change in HADS Depression Total Score From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).
Baseline and Week 6
Change in HADS Depression Total Score From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).
Baseline and Week 12
Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.
Baseline and Week 6
Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.
Baseline and Week 12
Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.
Baseline and Week 6
Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6
Time Frame: Baseline and Week 6
Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12
Time Frame: Baseline and Week 12
Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6
Time Frame: Baseline and Week 6
Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12
Time Frame: Baseline and Week 12
Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6
Time Frame: Baseline and Week 6
Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12
Time Frame: Baseline and Week 12
Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6
Time Frame: Baseline and Week 6
Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12
Time Frame: Baseline and Week 12
Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6
Time Frame: Baseline and Week 6
Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12
Time Frame: Baseline and Week 12
Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6
Time Frame: Baseline and Week 6
Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12
Time Frame: Baseline and Week 12
Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6
Time Frame: Baseline and Week 6
Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12
Time Frame: Baseline and Week 12
Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6
Time Frame: Baseline and Week 6
Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12
Time Frame: Baseline and Week 12
Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6
Time Frame: Baseline and Week 6
Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12
Time Frame: Baseline and Week 12
Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6
Time Frame: Baseline and Week 6
Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12
Time Frame: Baseline and Week 12
Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6
Time Frame: Baseline and Week 6
Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 6
Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12
Time Frame: Baseline and Week 12
Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).
Baseline and Week 12
Change in Clinical Global Impression - Severity Pain From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).
Baseline and Week 2
Change in Clinical Global Impression - Severity Pain From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).
Baseline and Week 6
Change in Clinical Global Impression - Severity Pain From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).
Baseline and Week 12
Change in Hamilton Depression Score From Baseline to Week 2
Time Frame: Baseline and Week 2
The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.
Baseline and Week 2
Change in Hamilton Depression Score From Baseline to Week 6
Time Frame: Baseline and Week 6
The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.
Baseline and Week 6
Change in Hamilton Depression Score From Baseline to Week 12
Time Frame: Baseline and Week 12
The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.
Baseline and Week 12
Suicidal Thoughts by BDI-II at Week 2
Time Frame: Week 2
Week 2
Suicidal Thoughts by BDI-II at Week 6
Time Frame: Week 6
Week 6
Suicidal Thoughts by BDI-II at Week 12
Time Frame: Week 12
Week 12
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2
Time Frame: Week 2
Week 2
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6
Time Frame: Week 6
Week 6
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12
Time Frame: Week 12
Week 12
Change of Fasting Blood Glucose From Baseline at Week 12
Time Frame: Baseline and Week 12
Ancova analysis controlling for baseline and insulin intake
Baseline and Week 12
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12
Time Frame: Baseline and Week 12
Ancova analysis controlling for baseline and insulin intake
Baseline and Week 12
Change of Systolic Blood Pressure From Baseline at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change of Diastolic Blood Pressure From Baseline at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change of Pulse Rate From Baseline at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimate)

February 16, 2009

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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