Efficacy of Lu 31-130 in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770744
• Other study ID #: 12396A
• Secondary ID: 2008-000479-11
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2008
• Last updated: November 7, 2016
• Start date: September 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Zicronapine
5-7mg/day; orally, encapsulated tablets, once daily
• Olanzapine
10-15mg/day; orally, encapsulated tablets, once daily

Locations

Country	Name	City	State
Czech Republic	CZ001	Ceske Budejovice
Czech Republic	CZ005	Litomerice
Czech Republic	CZ004	Lnare
Czech Republic	CZ002	Olomouc
Czech Republic	CZ003	Olomouc
Czech Republic	CZ006	Praha 8
France	FR001	Clermont-Ferrand, Cedex 1
France	FR002	Dole
France	FR003	Jonzac
Hong Kong	HK001	Hong Kong
Indonesia	ID001	Bangli
Indonesia	ID002	Jakarta
Philippines	PH002	Baguio
Philippines	PH001	Mandaluyong City
Poland	PL003	Gdansk
Poland	PL002	Lodz
Spain	ES001	Barcelona
Spain	ES002	Salamanca
Spain	ES004	Zamora
Thailand	TH001	Bangkok
Thailand	TH002	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Czech Republic,  France,  Hong Kong,  Indonesia,  Philippines,  Poland,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12		12 weeks	No
Secondary	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	Yes