DepressionPhase 4NCT01119924
A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain
A Phase 4 study testing Smilon® in people with Depression and Pain, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depression, Pain
- What is being tested?
- Smilon®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study for Evaluation 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.
- Conditions
- Depression, Pain
- Being tested
- Smilon®, Placebo
- Keywords
- Mirtazapine, Smilon, Depression, Pain
- Medical subject headings
- Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smilon®Drug
Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
PlaceboDrug
Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain intensity using the visual analog scale (VAS)
Measured: 8-week treatment
Secondary outcomes (3)
Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)
Measured: 8-week treatment
Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A)
Measured: 8-week treatment
Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire
Measured: 8-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buddhist Tzu Chi General Hospital
- Investigators
- Tsai Hsin Chi, Principal investigator, Buddhist Tzu Chi General Hospitsl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119924
- Sponsor's protocol ID
- IRB098-33
- Status last verified
- Jun 2011
- First submitted
- 6 May 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain
- ClinicalTrials.gov ID
- NCT01119924
- Acronym / sponsor ID
- IRB098-33
- Conditions
- Depression, Pain
- Keywords
- Mirtazapine, Smilon, Depression, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Buddhist Tzu Chi General Hospital
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Active comparator | Drug: Smilon®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 |
| Placebo | Placebo comparator | Drug: PlaceboSmilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smilon®Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks | Drug | Mirtazapine |
| PlaceboSmilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks | Drug | Placebo |
Primary outcome
Evaluation of pain intensity using the visual analog scale (VAS)
Time frame: 8-week treatment
3 secondary outcomes
Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)
Time frame: 8-week treatment
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
Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire
Time frame: 8-week treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsai Hsin Chi principal investigator
Buddhist Tzu Chi General Hospitsl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Smilon® in people with Depression and Pain, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain intensity using the visual analog scale (VAS) (time frame: 8-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.