NCT00304655

Acute Psychosis Treatment in the Long Term, Unitary Group Study (APLUS)

Multicenter, Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prove safety and efficacy of aripiprazole.

Detailed description

This study was designed to prove safety and efficacy of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder in Korea and to confirm the maintenance of efficacy and safety during maintenance period and the changes in emotional factors and social functions. After administering 15 mg/day of aripiprazole for two weeks, the test may change the dose within the range of 10 mg and 30 mg per day by clinical judgment. (Medication duration: 8 weeks (acute phase) + 18 weeks (maintenance phase)\] + 26 weeks (extension phase), \*total 52 weeks)

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-05-01
• Completion: 2007-10-01
• First posted: 2006-03-20
• Last updated: 2009-12-17

Locations

1 site across 1 country: South Korea