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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119924
• Other study ID #: IRB098-33
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2010
• Last updated: June 7, 2011
• Start date: December 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2011
• Source: Nang Kuang Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pain

Intervention

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

Locations

Country	Name	City	State
Taiwan	Nang Kuang Pharmaceutical Co., LTD	Tainan	Xinhua Township

Sponsors (2)

Lead Sponsor	Collaborator
Nang Kuang Pharmaceutical Co., Ltd.	Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain intensity using the visual analog scale (VAS)		8-week treatment	Yes
Secondary	Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)		8-week treatment	Yes
Secondary	Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A)		8-week treatment	Yes
Secondary	Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire		8-week treatment	Yes