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

June 7, 2011 updated by: Nang Kuang Pharmaceutical Co., Ltd.

Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Taiwan
    • Xinhua Township
      • Tainan, Xinhua Township, Taiwan
        • Nang Kuang Pharmaceutical Co., LTD

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)
Time Frame: 8-week treatment
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
8-week treatment
Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire
Time Frame: 8-week treatment
8-week treatment

Collaborators and Investigators

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

Sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Collaborators

Buddhist Tzu Chi General Hospital

Investigators

  • Principal Investigator: Tsai Hsin Chi, Buddhist Tzu Chi General Hospitsl

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

December 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB098-33

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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