NCT00770744

Efficacy of Lu 31-130 in Patients With Schizophrenia

A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.

Detailed description

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptom domains. Whereas positive symptoms respond to treatment the effects on negative symptoms and cognitive impairment are only very modest. Thus present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. Eligible patients will be randomised to blinded treatment with either flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment (olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms) and the safety of Lu 31-130 will be explored in comparison to olanzapine.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Zicronapine	5-7mg/day; orally, encapsulated tablets, once daily
DRUG	Olanzapine	10-15mg/day; orally, encapsulated tablets, once daily

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2008-10-10
• Last updated: 2016-11-08

Locations

21 sites across 8 countries: Czechia, France, Hong Kong, Indonesia, Philippines, Poland, Spain, Thailand