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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01119924

Enrollment

Registered

2010-05-10

Start date

2009-12-31

Completion date

2010-11-30

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Pain

Keywords

Mirtazapine, Smilon, Depression, Pain

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.

Interventions

DRUGSmilon®

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026