NCT01725282

Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder

Phase 2 Study of FK949E - Double-blind, Placebo-controlled, Comparative Study in Major Depressive Disorder Patients With Inadequate Response to Existing Antidepressants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	quetiapine extended release (XR)	Extended release tablets
DRUG	Placebo	matching tablets

Timeline

• Start date: 2011-12-14
• Primary completion: 2013-08-24
• Completion: 2013-08-24
• First posted: 2012-11-12
• Last updated: 2024-11-15
• Results posted: 2014-08-28

Locations

3 sites across 1 country: Japan