Major Depressive Disorder Patients Clinical Trial
Official title:
Phase I Study of FK949E - Multiple Dose Study of Non-Elderly Adult Patients With Major Depressive Disorder (MDD)
The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).
This is a dose-titration study. In low-dose-group, patients receive prescribed dose on Day 5 after 3-step dose increases. In high-dose-group patients receive prescribed dose on Day 7 after 4-step dose increases. Patients receive prescribed dose of FK949E for 7 days in each group. The dosage period is 12 days in low dose group and 14 days in high dose group. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01903200 -
Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder
|
Phase 1 |