A postmarketing clinical study of milnacipran hydrochloride (MIL001) for the treatment of depressio
- Conditions
- Major depression
- Registration Number
- JPRN-jRCT1080220706
- Lead Sponsor
- ASAHI KASEI PHARMA CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 705
Aged between 20 and 64 years at the time of giving consent.
A HAM-D17 total score of 18 and a score of 2 on the HAM-D item 1 Depressed mood at the time of giving consent and at the time of completing the run-in period.
A <25% decrease in the HAM-D17 total score during the run-in period.
Have had symptoms of depression for at least one month (30 days) and less than 12 months prior to giving written informed consent.
Patients who meet the following criteria during the relevant episode of depression:
1) Having received therapy with milnacipran hydrochloride or paroxetine hydrochloride hydrate for the relevant episode.
2) Not responded to therapies with two or more antidepressant drugs for the relevant episode.
3) Marked suicidal tendency (with 4 points according to HAM-D Score Item 3 Suicide)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HAM-D17 total score<br>Change in the HAM-D17 total score
- Secondary Outcome Measures
Name Time Method MADRS total score, CGI-I, SASS total score<br>Change in the MADRS total score, CGI-I improvement rate, Change in the SASS total score