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

Nang Kuang Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Depression; Pain

Treatments: Drug: Placebo; Drug: Smilon®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01119924

IRB098-33

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Mirtazapine

Active Comparator group

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

Treatment:

Drug: Smilon®

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo