Efficacy of Lu 31-130 in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine; Drug: Zicronapine

• Registration Number: NCT00770744
• Lead Sponsor: H. Lundbeck A/S

Brief 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• The subject has a primary diagnosis of schizophrenia
• The subject experiences clinically significant symptoms
• The subject is willing to be hospitalized during the initial period of the study
• The subject has normal serum values of parameters associated with liver function

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	-
Zicronapine	Zicronapine	-

Primary Outcome Measures

Name	Time	Method
Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in cognitive symptoms using Assessment of Cognition in Schizophrenia (BACS) test battery. Change in Clinical Global Impression/Improvement (CGI-S/I) scores. Change in Calgary Depression Scale for Schizophrenia (CDSS) score. Safety assessments.	12 weeks

Trial Locations

Locations (21)

CZ004; 🇨🇿 Lnare, Czech Republic

CZ002; 🇨🇿 Olomouc, Czech Republic

FR002; 🇫🇷 Dole, France

PL003; 🇵🇱 Gdansk, Poland

ES001; 🇪🇸 Barcelona, Spain

ES004; 🇪🇸 Zamora, Spain

ID001; 🇮🇩 Bangli, Indonesia

ID002; 🇮🇩 Jakarta, Indonesia

CZ006; 🇨🇿 Praha 8, Czech Republic

HK001; 🇭🇰 Hong Kong, Hong Kong

FR003; 🇫🇷 Jonzac, France

TH002; 🇹🇭 Chiang Mai, Thailand

ES002; 🇪🇸 Salamanca, Spain

FR001; 🇫🇷 Clermont-Ferrand, Cedex 1, France

CZ003; 🇨🇿 Olomouc, Czech Republic

PH001; 🇵🇭 Mandaluyong City, Philippines

PL002; 🇵🇱 Lodz, Poland

TH001; 🇹🇭 Bangkok, Thailand

CZ005; 🇨🇿 Litomerice, Czech Republic

PH002; 🇵🇭 Baguio, Philippines

CZ001; 🇨🇿 Ceske Budejovice, Czech Republic