A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain

Overview

The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either Smilon® or placebo, and will receive the treatment for 8 weeks in this study.

Full Title of Study: “Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2010

Interventions

  • Drug: Smilon®
    • Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
  • Drug: Placebo
    • Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks

Arms, Groups and Cohorts

  • Active Comparator: Mirtazapine
    • Mirtazapine 15mg/day or placebo once a day on the fist week, then 30 mg/day or placebo once a day, and then for 7 consecutive weeks
  • Placebo Comparator: Placebo
    • Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of pain intensity using the visual analog scale (VAS)
    • Time Frame: 8-week treatment

Secondary Measures

  • Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)
    • Time Frame: 8-week treatment
  • Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A)
    • Time Frame: 8-week treatment
  • Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire
    • Time Frame: 8-week treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female – Age 20-65 years – Diagnosis of at least one chronic pain syndrome and the diagnosis of concomitant depression according to DSM-IV criteria – Have a mean weekly pain score of at least 30 mm on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) before study entry Exclusion Criteria:

  • Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives – Known hypersensitivity to Mirtazapine or any of its components – Subjects who have a clinically significant or unstable medical or psychiatric condition – Subjects who have received nerve blocks or acupuncture for pain relief

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nang Kuang Pharmaceutical Co., Ltd.
  • Collaborator
    • Buddhist Tzu Chi General Hospital
  • Provider of Information About this Clinical Study
    • Hsu Cindy, Nang Kuang Pharmaceutical Co., LTD
  • Overall Official(s)
    • Tsai Hsin Chi, Principal Investigator, Buddhist Tzu Chi General Hospitsl

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