NCT05213143

The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine

The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single-arm and multi-center study for 16 weeks

Detailed description

An open-label, single-arm and multi-center study for 16 weeks, to study the improvement of weight gain in patients with schizophrenia who switched from olanzapine to lurasidone.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone	Lurasidone was oral administrated with a meal or within 30 min after eating in the evening. The maintenance dose of olanzapine from Day 0 to Day 6, than tapered until discontinuation from Day 7 to Day 27. Lurasidone initiated with 40mg/d on Day 0, maintained until Day 13, with a flexible dose (40-80mg/d, qd) from Day 28 to Day 111.

Timeline

• Start date: 2021-12-30
• Primary completion: 2022-11-18
• Completion: 2022-11-18
• First posted: 2022-01-28
• Last updated: 2024-04-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study