Major depression
Conditions
Interventions
investigational material(s)
Generic name etc : milnacipran hydrochloride
INN of investigational material : milnacipran
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for
Sponsors
ASAHI KASEI PHARMA CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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")
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAM-D17 total score Change in the HAM-D17 total score | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS total score, CGI-I, SASS total score Change in the MADRS total score, CGI-I improvement rate, Change in the SASS total score | — |
Outcome results
None listed