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Completed

NCT Number: NCT01119924

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nang Kuang Pharmaceutical Co., LTD

Tainan, Xinhua Township, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smilon®

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Evaluation of pain intensity using the visual analog scale (VAS)

    Time frame: 8-week treatment

Secondary outcomes

  1. Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)

    Time frame: 8-week treatment

  2. Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A)

    Time frame: 8-week treatment

  3. Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire

    Time frame: 8-week treatment

Sponsors and collaborators

Lead sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Buddhist Tzu Chi General Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 10, 2010
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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