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

Primary Purpose

Depression, Pain

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Smilon®

Placebo

About this trial

This is an interventional treatment trial for Depression focused on measuring Mirtazapine, Smilon, Depression, Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nang Kuang Pharmaceutical Co., LTD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mirtazapine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluation of pain intensity using the visual analog scale (VAS)

Secondary Outcome Measures

Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)

Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A)

Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire

Full Information

NCT ID

NCT01119924

First Posted

May 6, 2010

Last Updated

June 7, 2011

Sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Collaborators

Buddhist Tzu Chi General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01119924

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Collaborators

Buddhist Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Pain

Keywords

Mirtazapine, Smilon, Depression, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mirtazapine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Smilon®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluation of pain intensity using the visual analog scale (VAS)

Time Frame

8-week treatment

Secondary Outcome Measure Information:

Title

Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)

Time Frame

8-week treatment

Title

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

Title

Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire

Time Frame

8-week treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsai Hsin Chi

Organizational Affiliation

Buddhist Tzu Chi General Hospitsl

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nang Kuang Pharmaceutical Co., LTD

City

Tainan

State/Province

Xinhua Township

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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