Major depressive disorder
Conditions
Interventions
NC-2800 group or placebo group
Sponsors
Hayamizu Koki
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are 20 years of age or older and under 65 years of age at the time of informed consent. Gender not specified. Outpatients. Patients who understand the contents of the study and can provide written consent of their own free will. Others
Exclusion criteria
Exclusion criteria: Patients who test positive for HBs antigen, syphilis serology, HCV antibody, or HIV antigen/antibody at the time of screening. Patients with a history of severe drug allergy or hypersensitivity. Patients with a history of surgery in the gastrointestinal tract that affects drug absorption, such as gastrectomy, gastrointestinal suture, or intestinal resection. Patients with a history or concurrent hypotension. Pregnant women, lactating women, or female patients who test positive for a urine pregnancy test at screening, or male patients or female patients who wish to impregnate their partner during the study period or for 14 days after the end of the follow-up period. Also, male and female patients who cannot comply with contraception during the study period or for 14 days after the end of the follow-up period. Patients who have received NC-2800 in the past. Patients who have received any investigational drug within 3 months (90 days) prior to obtaining consent. Patients who are deemed inappropriate by the principal investigator or sub-investigator. Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression evaluation items | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Various depression evaluation items Safety: Incidence of adverse event incidence, Incidence of adverse reaction | — |
Contacts
Public ContactDevelopment Planning Department
Nippon Chemiphar Co., Ltd.
Outcome results
None listed