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

NCT01119924 | Completed Phase 4 DMC

• 1 other identifier: IRB098-33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Pain

Keywords

Mirtazapine; Smilon; Depression; Pain

Outcome Measures

Primary Outcomes (1)

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

  8-week treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Mirtazapine

ACTIVE COMPARATOR

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®

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Smilon® DRUG

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

Mirtazapine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nang Kuang Pharmaceutical Co., Ltd.: lead
• Buddhist Tzu Chi General Hospital: collaborator

Study Sites (1)

Nang Kuang Pharmaceutical Co., LTD

Tainan, Xinhua Township, Taiwan

Location

MeSH Terms

Conditions

Depression; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tsai Hsin Chi

  Buddhist Tzu Chi General Hospitsl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 10, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

TW (1)