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

Phase 4

Completed

• Conditions: Depression; Pain
• Interventions: Drug: Smilon®; Drug: Placebo

• Registration Number: NCT01119924
• Lead Sponsor: Nang Kuang Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Primary Completion: 2010-08
• Study Completion: 2010-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluation of pain intensity using the visual analog scale (VAS)	8-week treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nang Kuang Pharmaceutical Co., LTD; 🇨🇳 Tainan, Xinhua Township, Taiwan