NCT01810783

Brexpiprazole in Patients With Schizophrenia

Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of brexpiprazole during long-term treatment.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Brexpiprazole	1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-03-14
• Last updated: 2017-03-27
• Results posted: 2017-02-23

Locations

48 sites across 8 countries: United States, Estonia, Poland, Romania, Russia, Serbia, Slovakia, Ukraine