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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Collaborator: Buddhist Tzu Chi General Hospital
• Treatments: Mianserin; Mirtazapine

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