NCT01871974

Study to Evaluate Safety and Tolerability of FK949E in Patients With Major Depressive Disorder

Phase I Study of FK949E - Multiple Dose Study of Non-Elderly Adult Patients With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Major Depressive Disorder Patients

Interventions

Type	Name	Description
DRUG	FK949E	oral

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2013-06-07
• Last updated: 2017-02-16

Locations

2 sites across 1 country: Japan