Clinical trial NCT00770744: Efficacy of Lu 31-130 in Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic
Olanzapine
Lu 31-130
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ceske Budejovice
country: Czech Republic
facility: CZ001
city: Litomerice
country: Czech Republic
facility: CZ005
city: Lnare
country: Czech Republic
facility: CZ004
city: Olomouc
country: Czech Republic
facility: CZ002
city: Olomouc
country: Czech Republic
facility: CZ003
city: Praha 8
country: Czech Republic
facility: CZ006
city: Clermont-Ferrand, Cedex 1
country: France
facility: FR001
city: Dole
country: France
facility: FR002
city: Jonzac
country: France
facility: FR003
city: Hong Kong
country: Hong Kong
facility: HK001
city: Bangli
country: Indonesia
facility: ID001
city: Jakarta
country: Indonesia
facility: ID002
city: Baguio
country: Philippines
facility: PH002
city: Mandaluyong City
country: Philippines
facility: PH001
city: Gdansk
country: Poland
facility: PL003
city: Lodz
country: Poland
facility: PL002
city: Barcelona
country: Spain
facility: ES001
city: Salamanca
country: Spain
facility: ES002
city: Zamora
country: Spain
facility: ES004
city: Bangkok
country: Thailand
facility: TH001
city: Chiang Mai
country: Thailand
facility: TH002
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: