NCT01903200

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

Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 65 Years – 80 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 elderly patients with major depressive disorder (MDD).

Conditions

• Major Depressive Disorder Patients

Interventions

Type	Name	Description
DRUG	FK949E	Oral

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2013-07-19
• Last updated: 2017-02-16

Locations

2 sites across 1 country: Japan