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

This study has been completed.
Sponsor:
Collaborator:
Buddhist Tzu Chi General Hospital
Information provided by:
Nang Kuang Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01119924
First received: May 6, 2010
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Depression
Pain
Drug: Smilon®
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain

Resource links provided by NLM:


Further study details as provided by Nang Kuang Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Evaluation of pain intensity using the visual analog scale (VAS) [ Time Frame: 8-week treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS) [ Time Frame: 8-week treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire [ Time Frame: 8-week treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2009
Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mirtazapine
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
Drug: Smilon®
Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
Placebo Comparator: Placebo
Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
Drug: Placebo
Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119924

Locations
Taiwan
Nang Kuang Pharmaceutical Co., LTD
Tainan, Xinhua Township, Taiwan
Sponsors and Collaborators
Nang Kuang Pharmaceutical Co., Ltd.
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Tsai Hsin Chi Buddhist Tzu Chi General Hospitsl
  More Information

No publications provided

Responsible Party: Hsu Cindy, Nang Kuang Pharmaceutical Co., LTD
ClinicalTrials.gov Identifier: NCT01119924     History of Changes
Other Study ID Numbers: IRB098-33
Study First Received: May 6, 2010
Last Updated: June 7, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Nang Kuang Pharmaceutical Co., Ltd.:
Mirtazapine
Smilon
Depression
Pain

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Mirtazapine
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on July 31, 2014