NCT00704509

Efficacy of Bifeprunox in Patients With Schizophrenia

A Multinational, Randomised, Double-Blind, Fixed-Dose, Bifeprunox Study Combining a 12-Week Placebo-Controlled, Quetiapine-Referenced Phase With a 12-Month Quetiapine-Controlled Phase in Patients With Schizophrenia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

Detailed description

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11915A).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Bifeprunox	20 mg daily, encapsulated tablets, orally, 12 months
DRUG	Placebo	Encapsulated tablets, orally, 12 weeks
DRUG	Quetiapine	600 mg daily, encapsulated tablets, orally, 12 months

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-08-01
• Completion: 2009-11-01
• First posted: 2008-06-25
• Last updated: 2010-09-27

Locations

45 sites across 7 countries: India, Indonesia, Malaysia, Philippines, Poland, South Korea, Ukraine