NCT02142556

The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics

The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in patients with schizophrenia switched from other antipsychotics which were suboptimal due to insufficient efficacy or insufficient tolerability. Methods: This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerability of the patients.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Administration of quetiapine XR	The treatment was initiated with a 7-day cross-titration period. Previous antipsychotic medication was maintained at the original dose from day 1 to day 3; then reduced to 50% of the original dose from day 4 to day 7 and discontinued on day 8. Meanwhile, the patients started quetiapine XR with daily dose at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerability of the patients.

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2014-05-20
• Last updated: 2014-05-20

Locations

1 site across 1 country: Taiwan